Adolescent DevelopmentNCT00729378

Jump-In: Building Better Bones

A study testing Skeletal loading in people with Adolescent Development, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The Jump-In study will prospectively assess the effects of impact exercise on skeletal development in young girls, including bone mass, bone mineral density, and bone geometry. We hypothesize that girls who regularly participate in impact loading exercise will accrue greater skeletal mass, increase bone density and… Read more about this study

Who is it for?: Ages 9 to 12 years, women onlyHealthy volunteers can take part
Conditions the study is for: Adolescent Development
What is being tested?: Skeletal loading
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 509 participants
Where: 1 siteUnited States
Study dates: Apr 2007to Apr 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 12 years
Women only
Healthy volunteers accepted
Child

Who may be able to join

female; entering 4th or 6th grade at enrollment; and willing and able to undergo all of the testing requirements; no physical conditions that limit participation in physical activity/exercise; able to read and write English.

Who cannot join

Girls with severe learning disabilities (identified by schools), who are unable to complete questionnaires or otherwise comply with assessment protocols will be excluded. Any subjects (or potential subjects) suffering from medical conditions and/or disabilities that would limit their participation in exercise will be excluded from the study, following the American Academy of Pediatrics (AAP) guidelines. Further, any volunteers who are taking medications that would limit exercise and/or alter bone mineral accrual will also be excluded from the study. Girls with a positive pregnancy screening test at the time of the lab visit before DXA scanning will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arizona-Ina Gittings Bldg. #93
Tucson, Arizona, 85721

Other trials in United States

About this study

Official title: Exercise and Bone Development in Young Girls

Read the detailed description

Jump-In is a school-based, block-randomized, trial of the effects of impact-loading exercise on skeletal development in prepubescent and early pubescent girls. Fourth (n=~200) and sixth (n=~200) grade girls in 14 Tucson (Arizona) schools with no contraindication to physical exercise will be enrolled. Girls in intervention schools will participate in impact activities 3 times per week at school, progressively increasing the number (up to 40) of jumps and their height (from 6 inches to 18 inches per repetition) over the initial 2 months. Thereafter, new activities will be introduced approximately every 2-3 months to maintain interest and motivation, and continually stress the skeleton in novel ways, over 2 years of intervention. Physical and behavioral assessments will be done in both intervention and control groups at baseline, end of the initial school year, and yearly thereafter for 5 years. Assessments include height and weight, selected skeletal lengths, fat, lean soft tissue, bone mineral content and areal density from dual energy x-ray absorptiometry (DXA), and bone geometry (e.g., cortical thickness, periosteal circumference and cortical and trabecular density) and muscle area from peripheral quantitative computed tomography (pQCT). Also, maturation will be assessed via the Tanner Stage (self-assessment against standardized drawings of stages of physical development), diet from the Harvard Youth Food Frequency Questionnaire, and physical activity using pedometers and standardized questionnaires. We hypothesize that girls in intervention schools will demonstrate enhanced skeletal development, including greater mineral mass and density, and enhanced bone geometry, leading to greater bone strength compared to girls in control schools. We further hypothesize that younger (Tanner Stage 1) girls will experience greater adaptations than older girls (Tanner 2 and 3), and that positive adaptations will be maintained throughout the 3-year follow-up period.

Conditions: Adolescent Development
Being tested: Skeletal loading

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Skeletal loadingOther
Impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities will be introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.

Study groups in NCT00729378
Study group	Role	What they receive
Exercise Intervention	Experimental	Implementation of intervention program designed to provide skeletal loading through high impact activities. All activities performed by subjects in exercise intervention arm will be assessed by physical activity questionnaire and use of pedometer. Have baseline anthropometric measurements, total body DXA scans and peripheral quantitative computed tomography (pQCT) scans of the tibia and femur. Receives: Other: Skeletal loading
Control	No intervention	Participants in this arm will not take part in exercise intervention. All activities performed by subjects in control arm will be assessed by physical activity questionnaire and use of pedometer. Have baseline anthropometric measurements, total body DXA scans and peripheral quantitative computed tomography (pQCT) scans of the tibia and femur.

What is being measured

The primary outcome is the main question the study is designed to answer.

Baseline Total Volumetric Bone Density at the Femur 4% Site
Baseline (initial) measurement of total volumetric bone density at the femur 4% site. Measurement made by peripheral quantitative computed tomography (pQCT) at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Volumetric Bone Density of Cortical Bone at the Femur 4% Site
Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Trabecular Bone Area at the Femur 4% Site
Baseline (initial) measurement of trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline
Baseline Cortical Bone Area at the Femur 4% Site
Baseline (initial) measurement of cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline
Baseline Periosteal Circumference at the Femur 4% Site
Baseline (initial) measurement of periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline
Baseline Bone Strength Index at the Femur 4% Site
Baseline (initial) measurement of bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
Measured: Baseline
Baseline Total Volumetric Bone Density at the Femur 20% Site
Baseline (initial) measurement of total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Volumetric Bone Density of Cortical Bone at the Femur 20% Site
Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Periosteal Circumference at the Femur 20% Site
Baseline (initial) measurement of periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline
Baseline Cortical Thickness at the Femur 20% Site
Baseline (initial) measurement of cortical thickness at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline
Baseline Stress-Strain Index at the Femur 20% Site
Baseline (initial) measurement of stress-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.
Measured: Baseline
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Total Volumetric Bone Density at the Tibia 4% Site
Baseline (initial) measurement of total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Trabecular Bone Area at the Tibia 4% Site
Baseline (initial) measurement of trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline
Baseline Cortical Bone Area at the Tibia 4% Site
Baseline (initial) measurement of cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline
Baseline Periosteal Circumference at the Tibia 4% Site
Baseline (initial) measurement of periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline
Baseline Bone Strength Index at the Tibia 4% Site
Baseline (initial) measurement of bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
Measured: Baseline
Baseline Total Volumetric Bone Density at the Tibia 50% Site
Baseline (initial) measurement of total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Periosteal Circumference at the Tibia 50% Site
Baseline (initial) measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline
Baseline Cortical Thickness at the Tibia 50% Site
Baseline (initial) measurement of cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline
Baseline Stress-Strain Index at the Tibia 50% Site
Baseline (initial) measurement of stress-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.
Measured: Baseline
Baseline Total Volumetric Bone Density at the Tibia 66% Site
Baseline (initial) measurement of total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline
Baseline Periosteal Circumference at the Tibia 66% Site
Baseline (initial) measurement of periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline
Baseline Cortical Thickness at the Tibia 66% Site
Baseline (initial) measurement of cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline
Baseline Stress-Strain Index at the Tibia 66% Site
Baseline (initial) measurement of strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.
Measured: Baseline
12-month Change in Total Volumetric Bone Density the Femur 4% Site
Baseline to 12-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site
Baseline to 12-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Trabecular Bone Area at the Femur 4% Site
Baseline to 12-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline to 12-months
12-month Change in Cortical Bone Area at the Femur 4% Site
Baseline to 12-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline to 12-months
12-month Change in Periosteal Circumference at the Femur 4% Site
Baseline to 12-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 12-months
12-month Change in Bone Strength Index at the Femur 4% Site
Baseline to 12-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
Measured: Baseline to 12-months
12-month Change in Total Volumetric Bone Density at the Femur 20% Site
Baseline to 12-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site
Baseline to 12-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Thickness of Cortical Bone at the Femur 20% Site
Baseline to 12-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units millimeters (mm).
Measured: Baseline to 12-months
12-month Change in Periosteal Circumference at the Femur 20% Site
Baseline to 12-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 12-months
12-month Change in Stress-Strain Index at the Femur 20% Site
Baseline to 12-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.
Measured: Baseline to 12-months
12-month Change in Total Volumetric Bone Density at the Tibia 4% Site
Baseline to 12-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Trabecular Bone Area at the Tibia 4% Site
Baseline to 12-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline to 12-months
12-month Change in Cortical Bone Area at the Tibia 4% Site
Baseline to 12-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline to 12-months
12-month Change in Periosteal Circumference at the Tibia 4% Site
Baseline to 12-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 12-months
12-month Change in Bone Strength Index at the Tibia 4% Site
Baseline to 12-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
Measured: Baseline to 12-months
12-month Change in Total Volumetric Bone Density at the Tibia 50% Site
Baseline to 12-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Periosteal Circumference at the Tibia 50% Site
Baseline to 12-month change in periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 12-months
12-month Change in Cortical Thickness at the Tibia 50% Site
Baseline to 12-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 12-months
12-month Change in Stress-Strain Index at the Tibia 50% Site
Baseline to 12-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.
Measured: Baseline to 12-months
12-month Change in Total Volumetric Bone Density at the Tibia 66% Site
Baseline to 12-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 12-months
12-month Change in Periosteal Circumference at the Tibia 66% Site
Baseline to 12-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 12-months
12-month Change in Cortical Thickness at the Tibia 66% Site
Baseline to 12-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 12-months
12-month Change in Stress-Strain Index at the Tibia 66% Site
Baseline to 12-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.
Measured: Baseline to 12-months
24-month in Change in Total Volumetric Bone Density the Femur 4% Site
Baseline to 24-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units mg/ccm.
Measured: Baseline to 24-months
24-month in Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month in Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site
Baseline to 24-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Trabecular Bone Area at the Femur 4% Site
Baseline to 24-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline to 24-months
24-month Change in Cortical Bone Area at the Femur 4% Site
Baseline to 24-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline to 24-months
24-month Change in Periosteal Circumference at the Femur 4% Site
Baseline to 24-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 24-months
24-month Change in Bone Strength Index at the Femur 4% Site
Baseline to 24-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
Measured: Baseline to 24-months
24-month Change in Total Volumetric Bone Density at the Femur 20% Site
Baseline to 24-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site
Baseline to 24-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Thickness of Cortical Bone at the Femur 20% Site
Baseline to 24-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 24-months
24-month Change in Periosteal Circumference at the Femur 20% Site
Baseline to 24-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 24-months
24-month Change in Stress-Strain Index at the Femur 20% Site
Baseline to 24-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.
Measured: Baseline to 24-months
24-month Change in Total Volumetric Bone Density at the Tibia 4% Site
Baseline to 24-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Trabecular Bone Area at the Tibia 4% Site
Baseline to 24-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline to 24-months
24-month Change in Cortical Bone Area at the Tibia 4% Site
Baseline to 24-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
Measured: Baseline to 24-months
24-month Change in Periosteal Circumference at the Tibia 4% Site
Baseline to 24-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 24-months
24-month Change in Bone Strength Index at the Tibia 4% Site
Baseline to 24-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
Measured: Baseline to 24-months
24-month Change in Total Volumetric Bone Density at the Tibia 50% Site
Baseline to 24-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Periosteal Circumference at the Tibia 50% Site
Baseline to 24-month measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 24-months
24-month Change in Cortical Thickness at the Tibia 50% Site
Baseline to 24-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 24-months
24-month Change in Stress-Strain Index at the Tibia 50% Site
Baseline to 24-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.
Measured: Baseline to 24-months
24-month Change in Total Volumetric Bone Density at the Tibia 66% Site
Baseline to 24-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Measured: Baseline to 24-months
24-month Change in Periosteal Circumference at the Tibia 66% Site
Baseline to 24-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 24-months
24-month Change in Cortical Thickness at the Tibia 66% Site
Baseline to 24-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Measured: Baseline to 24-months
24-month Change in Stress-Strain Index at the Tibia 66% Site
Baseline to 24-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.
Measured: Baseline to 24-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Apr 2013

First posted7 Aug 2008 (estimated)
Study startApr 2007
Primary completionApr 2012
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 509 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00729378
Sponsor's protocol ID: HD050775
Status last verified: Mar 2021
First submitted: 5 Aug 2008
Last updated: 28 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Farr JN, Van Loan MD, Lohman TG, Going SB. Lower physical activity is associated with skeletal muscle fat content in girls. Med Sci Sports Exerc. 2012 Jul;44(7):1375-81. doi: 10.1249/MSS.0b013e31824749b2.
PubMed 22217562
Farr JN, Tomas R, Chen Z, Lisse JR, Lohman TG, Going SB. Lower trabecular volumetric BMD at metaphyseal regions of weight-bearing bones is associated with prior fracture in young girls. J Bone Miner Res. 2011 Feb;26(2):380-7. doi: 10.1002/jbmr.218.
PubMed 20721933

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exercise and Bone Development in Young Girls
ClinicalTrials.gov ID: NCT00729378
Acronym / sponsor ID: HD050775
Conditions: Adolescent Development
Study type: Interventional
Recruitment status: Completed
Enrolment: 509 participants (actual)
Lead sponsor: University of ArizonaUniversity, hospital or other
Study start: Apr 2007
Primary completion: Apr 2012 (actual)
Study completion: Apr 2013 (actual)
First posted: 7 Aug 2008 (estimated)
Results: Posted 8 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Exercise Intervention	Experimental	Other: Skeletal loadingImplementation of intervention program designed to provide skeletal loading through high impact activities. All activities performed by subjects in exercise intervention arm will be assessed by physical activity questionnaire and use of pedometer. Have baseline anthropometric measurements, total body DXA scans and peripheral quantitative computed tomography (pQCT) scans of the tibia and femur.
Control	No intervention	–Participants in this arm will not take part in exercise intervention. All activities performed by subjects in control arm will be assessed by physical activity questionnaire and use of pedometer. Have baseline anthropometric measurements, total body DXA scans and peripheral quantitative computed tomography (pQCT) scans of the tibia and femur.

Who may qualify

Ages: 9 to 12 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

female; entering 4th or 6th grade at enrollment; and willing and able to undergo all of the testing requirements; no physical conditions that limit participation in physical activity/exercise; able to read and write English.

Key exclusion criteria (1 listed)

Girls with severe learning disabilities (identified by schools), who are unable to complete questionnaires or otherwise comply with assessment protocols will be excluded. Any subjects (or potential subjects) suffering from medical conditions and/or disabilities that would limit their participation in exercise will be excluded from the study, following the American Academy of Pediatrics (AAP) guidelines. Further, any volunteers who are taking medications that would limit exercise and/or alter bone mineral accrual will also be excluded from the study. Girls with a positive pregnancy screening test at the time of the lab visit before DXA scanning will be excluded.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Skeletal loadingImpact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities will be introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.	Other	Exercise Intervention

Primary outcome

Baseline Total Volumetric Bone Density at the Femur 4% Site
Time frame: Baseline
Baseline (initial) measurement of total volumetric bone density at the femur 4% site. Measurement made by peripheral quantitative computed tomography (pQCT) at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
Time frame: Baseline
Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Volumetric Bone Density of Cortical Bone at the Femur 4% Site
Time frame: Baseline
Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Trabecular Bone Area at the Femur 4% Site
Time frame: Baseline
Baseline (initial) measurement of trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
Baseline Cortical Bone Area at the Femur 4% Site
Time frame: Baseline
Baseline (initial) measurement of cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
Baseline Periosteal Circumference at the Femur 4% Site
Time frame: Baseline
Baseline (initial) measurement of periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Baseline Bone Strength Index at the Femur 4% Site
Time frame: Baseline
Baseline (initial) measurement of bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
Baseline Total Volumetric Bone Density at the Femur 20% Site
Time frame: Baseline
Baseline (initial) measurement of total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
Time frame: Baseline
Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Volumetric Bone Density of Cortical Bone at the Femur 20% Site
Time frame: Baseline
Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Periosteal Circumference at the Femur 20% Site
Time frame: Baseline
Baseline (initial) measurement of periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Baseline Cortical Thickness at the Femur 20% Site
Time frame: Baseline
Baseline (initial) measurement of cortical thickness at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Baseline Stress-Strain Index at the Femur 20% Site
Time frame: Baseline
Baseline (initial) measurement of stress-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
Time frame: Baseline
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Total Volumetric Bone Density at the Tibia 4% Site
Time frame: Baseline
Baseline (initial) measurement of total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
Time frame: Baseline
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Trabecular Bone Area at the Tibia 4% Site
Time frame: Baseline
Baseline (initial) measurement of trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
Baseline Cortical Bone Area at the Tibia 4% Site
Time frame: Baseline
Baseline (initial) measurement of cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
Baseline Periosteal Circumference at the Tibia 4% Site
Time frame: Baseline
Baseline (initial) measurement of periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Baseline Bone Strength Index at the Tibia 4% Site
Time frame: Baseline
Baseline (initial) measurement of bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
Baseline Total Volumetric Bone Density at the Tibia 50% Site
Time frame: Baseline
Baseline (initial) measurement of total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
Time frame: Baseline
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
Time frame: Baseline
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Periosteal Circumference at the Tibia 50% Site
Time frame: Baseline
Baseline (initial) measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Baseline Cortical Thickness at the Tibia 50% Site
Time frame: Baseline
Baseline (initial) measurement of cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Baseline Stress-Strain Index at the Tibia 50% Site
Time frame: Baseline
Baseline (initial) measurement of stress-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.
Baseline Total Volumetric Bone Density at the Tibia 66% Site
Time frame: Baseline
Baseline (initial) measurement of total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
Time frame: Baseline
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
Time frame: Baseline
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Baseline Periosteal Circumference at the Tibia 66% Site
Time frame: Baseline
Baseline (initial) measurement of periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Baseline Cortical Thickness at the Tibia 66% Site
Time frame: Baseline
Baseline (initial) measurement of cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Baseline Stress-Strain Index at the Tibia 66% Site
Time frame: Baseline
Baseline (initial) measurement of strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.
12-month Change in Total Volumetric Bone Density the Femur 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Trabecular Bone Area at the Femur 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
12-month Change in Cortical Bone Area at the Femur 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
12-month Change in Periosteal Circumference at the Femur 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
12-month Change in Bone Strength Index at the Femur 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
12-month Change in Total Volumetric Bone Density at the Femur 20% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Thickness of Cortical Bone at the Femur 20% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units millimeters (mm).
12-month Change in Periosteal Circumference at the Femur 20% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
12-month Change in Stress-Strain Index at the Femur 20% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.
12-month Change in Total Volumetric Bone Density at the Tibia 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Trabecular Bone Area at the Tibia 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
12-month Change in Cortical Bone Area at the Tibia 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
12-month Change in Periosteal Circumference at the Tibia 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
12-month Change in Bone Strength Index at the Tibia 4% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
12-month Change in Total Volumetric Bone Density at the Tibia 50% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Periosteal Circumference at the Tibia 50% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
12-month Change in Cortical Thickness at the Tibia 50% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
12-month Change in Stress-Strain Index at the Tibia 50% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.
12-month Change in Total Volumetric Bone Density at the Tibia 66% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
12-month Change in Periosteal Circumference at the Tibia 66% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
12-month Change in Cortical Thickness at the Tibia 66% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
12-month Change in Stress-Strain Index at the Tibia 66% Site
Time frame: Baseline to 12-months
Baseline to 12-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.
24-month in Change in Total Volumetric Bone Density the Femur 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units mg/ccm.
24-month in Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month in Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Trabecular Bone Area at the Femur 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
24-month Change in Cortical Bone Area at the Femur 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).
24-month Change in Periosteal Circumference at the Femur 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
24-month Change in Bone Strength Index at the Femur 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
24-month Change in Total Volumetric Bone Density at the Femur 20% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Thickness of Cortical Bone at the Femur 20% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
24-month Change in Periosteal Circumference at the Femur 20% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
24-month Change in Stress-Strain Index at the Femur 20% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.
24-month Change in Total Volumetric Bone Density at the Tibia 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Trabecular Bone Area at the Tibia 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
24-month Change in Cortical Bone Area at the Tibia 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).
24-month Change in Periosteal Circumference at the Tibia 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
24-month Change in Bone Strength Index at the Tibia 4% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.
24-month Change in Total Volumetric Bone Density at the Tibia 50% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Periosteal Circumference at the Tibia 50% Site
Time frame: Baseline to 24-months
Baseline to 24-month measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
24-month Change in Cortical Thickness at the Tibia 50% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
24-month Change in Stress-Strain Index at the Tibia 50% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.
24-month Change in Total Volumetric Bone Density at the Tibia 66% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
24-month Change in Periosteal Circumference at the Tibia 66% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
24-month Change in Cortical Thickness at the Tibia 66% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
24-month Change in Stress-Strain Index at the Tibia 66% Site
Time frame: Baseline to 24-months
Baseline to 24-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.

Results and safety

Results posted to the registry on 8 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exercise Intervention	430	292
Control	309	217

Primary outcome: Baseline Total Volumetric Bone Density at the Femur 4% Site

Time frame: Baseline. Mean (Standard Deviation). Unit: milligrams per cubic centimeter (mg/ccm)

Measure	Exercise Intervention n = 286	Control n = 217
Value	277.25 (33.83)	270.79 (32.97)

Population analysed: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).

Primary outcome: Baseline Volumetric Bone Density of Trabecular Bone at the Femur 4% Site

Time frame: Baseline. Mean (Standard Deviation). Unit: milligrams per cubic centimeter (mg/ccm)

Measure	Exercise Intervention n = 286	Control n = 217
Value	239.32 (32.2)	232.34 (31.56)

Primary outcome: Baseline Volumetric Bone Density of Cortical Bone at the Femur 4% Site

Time frame: Baseline. Mean (Standard Deviation). Unit: milligrams per cubic centimeter (mg/ccm)

Measure	Exercise Intervention n = 286	Control n = 217
Value	273.80 (31.23)	267.89 (30.75)

Primary outcome: Baseline Trabecular Bone Area at the Femur 4% Site

Time frame: Baseline. Mean (Standard Deviation). Unit: millimeters squared (mm^2)

Measure	Exercise Intervention n = 286	Control n = 217
Value	1039.55 (220.17)	1053.15 (227.32)

Adverse events

Time frame: Since the time frame was based on a "school year", adverse event data were collected twice a year (at the end of each school semester) for up to 5 years (the duration of the study).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exercise Intervention Arm	0 of 292 (0%)	0 of 292 (0%)	Not reported
Control Arm	0 of 217 (0%)	0 of 217 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22217562Farr JN, Van Loan MD, Lohman TG, Going SB. Lower physical activity is associated with skeletal muscle fat content in girls. Med Sci Sports Exerc. 2012 Jul;44(7):1375-81. doi: 10.1249/MSS.0b013e31824749b2.
Derived from this study: PubMed 20721933Farr JN, Tomas R, Chen Z, Lisse JR, Lohman TG, Going SB. Lower trabecular volumetric BMD at metaphyseal regions of weight-bearing bones is associated with prior fracture in young girls. J Bone Miner Res. 2011 Feb;26(2):380-7. doi: 10.1002/jbmr.218.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott Going, Ph.D. principal investigator

University of Arizona-Dept. of Nutritional Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Skeletal loading in people with Adolescent Development, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Total Volumetric Bone Density at the Femur 4% Site (time frame: Baseline). The study lists 96 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00729378, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.