Bone Mineral Density Reference DataNCT02162602
Bone Mineral Accretion in Young Children
An observational study of Bone Mineral Density Reference Data, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
Compromised bone strength and increased fracture susceptibility pose significant morbidity and health care costs in children. Inadequate childhood bone accretion also may have lifelong consequences. Bone fragility among children with chronic medical conditions is a special concern. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Mineral Density Reference Data
- How many people
- 484 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Community sample
Who may be able to join
- We will enroll healthy, normally growing children free from medical conditions that may affect bone or growth between the ages of 1-5 years.
Who cannot join
- Weight, length and weight-for-length outside ± 2 Standard Deviations of the 2006 World Health Organization growth standard for ages 1 to 2 y and the 3rd to 97th percentiles of the Centers for Disease Control 2000 growth reference for ages ≥ 2 years as recommended;84 chronic medical conditions affecting bone density (e.g., cancer, kidney, gastrointestinal, musculoskeletal or endocrine disorder); chronic use of medications that affect bone (glucocorticoids, anti-epileptics, or hormones); prior fracture; dietary restrictions; preterm birth (<37 wk gestation) and low birth weight (<2500 g).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Compromised bone strength and increased fracture susceptibility pose significant morbidity and health care costs in children. Inadequate childhood bone accretion also may have lifelong consequences. Bone fragility among children with chronic medical conditions is a special concern. Identifying children at-risk for bone fragility and factors affecting bone strength requires understanding normal bone development. Dual energy x-ray absorptiometry (DXA) is the most common method for measuring bone mineral content and bone density in children. There are bone density reference data for children ages 5-20 years. An important gap is the lack of reference data for children ages < 5 years, who also experience numerous medical conditions that threaten their bone health.
Growth and body composition influence bone mineral accrual, and are important for interpreting bone density measurements in children with conditions that threaten bone health. Gross motor skills and subsequent physical activity may also affect bone accrual. Children with chronic illness are at risk of altered body composition, delayed growth and gross motor skills, and restricted physical activity. Understanding independent effects of growth, body composition, gross motor skills and physical activity on bone accrual will improve interpretation of bone density measurements and has important research and clinical applications for identifying risk factors and therapies for young children.
This study will involve a longitudinal cohort of 280 children studied every 6 months for 3 years, and a cross-sectional cohort of 240 children measured once. The study will be conducted at 2 clinical centers [Cincinnati Children's Hospital Medical Center (CCHMC) and the Children's Hospital of Philadelphia (CHOP)] with equal enrollment at both centers. Measurements will include bone density, growth and body composition, dietary intake, sleep, physical activity and gross motor skills. Results from this study will enable clinical bone health assessment of young children with disorders that threaten bone health, and identify factors that affect bone accrual.
Read the detailed description
This study seeks to understand bone mineral accrual in children 1 to 5 years of age. Many young children have chronic medical conditions that threaten bone health and increase their susceptibility to fractures. Over the last 10 years our team at Cincinnati Children's Hospital Medical Center (CCHMC) has helped develop reference data that have enabled clinicians to identify children 5 to 20 y with low bone density for age and optimize their medical care. A glaring deficit is the inability to evaluate bone health of young children < 5 y due to lack of appropriate bone density reference data. This gap is problematic as there are numerous clinical conditions (e.g., neuromuscular disease, cancer, glucocorticoid treatment, extreme prematurity) that threaten bone health in this young age group.
The primary goal of our new study is to develop bone mass and density reference data to aid identification of children 1 to 5 years of age with bone deficits. A first step is to characterize the age-related changes in bone accrual at multiple skeletal sites and determine when sex and race differences in bone mass and density emerge.
The second goal of this study is to assess the influence of growth, body composition, gross motor skills and physical activity on bone mineral accrual in young children. In older children, the need to account for growth and lean mass when interpreting bone measurements has been demonstrated. The best way to do this in young children is unknown. Pronounced changes in gross motor skills, locomotion and physical activity also occur during early childhood. It is well appreciated that mechanical loads on the growing skeleton promote bone mineral accrual. but how gross motor skills and physical activity impact bone development in children 1 to 5 years of age is unknown. Understanding the impact of growth, body composition, motor skill development, and physical activity on bone accrual in young children is important for interpretation of clinical bone density measurements. These characteristics are often affected in young children with chronic medical conditions.
This study will enroll 520 healthy children between 1 to 5 years of age; half will be recruited at CCHMC and half at Children's Hospital of Philadelphia.
This study is unique since no previous studies have addressed these issues in children 1-5 y. It is clinically relevant as findings will facilitate medical care of children with chronic medical conditions that threaten bone health, and it will develop and validate novel methods for bone and body composition assessment in this age range. It will also add generalizable knowledge to enhance understanding of the growing skeleton, and its relationship to motor and somatic development. Since poor bone mineral accrual can have lifelong consequences, this study addresses the major public health concern of osteoporosis.
- Conditions
- Bone Mineral Density Reference Data
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: Baseline
Secondary outcomes (1)
Bone mineral content
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Mineral Density Reference DataStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of California, San Francisco, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Heidi Kalkwarf, PhD, Principal investigator, Cincinnati Children'sBabette Zemel, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162602
- Sponsor's protocol ID
- CIN-001_Bone Mineral Accretion
- Other IDs
- R01HD076321
- Status last verified
- Jul 2019
- First submitted
- 11 Jun 2014
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Accretion in Young Children
- ClinicalTrials.gov ID
- NCT02162602
- Acronym / sponsor ID
- CIN-001_Bone Mineral Accretion
- Conditions
- Bone Mineral Density Reference Data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of California, San Francisco, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compromised bone strength and increased fracture susceptibility pose significant morbidity and health care costs in children. Inadequate childhood bone accretion also may have lifelong consequences. Bone fragility among children with chronic medical conditions is a special concern. Identifying children at-risk for bone fragility and factors affecting bone strength requires understanding normal bone development. Dual energy x-ray absorptiometry (DXA) is the most common method for measuring bone mineral content and bone density in children. There are bone density reference data for children ages 5-20 years. An important gap is the lack of reference data for children ages < 5 years, who also experience numerous medical conditions that threaten their bone health.
Growth and body composition influence bone mineral accrual, and are important for interpreting bone density measurements in children with conditions that threaten bone health. Gross motor skills and subsequent physical activity may also affect bone accrual. Children with chronic illness are at risk of altered body composition, delayed growth and gross motor skills, and restricted physical activity. Understanding independent effects of growth, body composition, gross motor skills and physical activity on bone accrual will improve interpretation of bone density measurements and has important research and clinical applications for identifying risk factors and therapies for young children.
This study will involve a longitudinal cohort of 280 children studied every 6 months for 3 years, and a cross-sectional cohort of 240 children measured once. The study will be conducted at 2 clinical centers [Cincinnati Children's Hospital Medical Center (CCHMC) and the Children's Hospital of Philadelphia (CHOP)] with equal enrollment at both centers. Measurements will include bone density, growth and body composition, dietary intake, sleep, physical activity and gross motor skills. Results from this study will enable clinical bone health assessment of young children with disorders that threaten bone health, and identify factors that affect bone accrual.
Detailed description
This study seeks to understand bone mineral accrual in children 1 to 5 years of age. Many young children have chronic medical conditions that threaten bone health and increase their susceptibility to fractures. Over the last 10 years our team at Cincinnati Children's Hospital Medical Center (CCHMC) has helped develop reference data that have enabled clinicians to identify children 5 to 20 y with low bone density for age and optimize their medical care. A glaring deficit is the inability to evaluate bone health of young children < 5 y due to lack of appropriate bone density reference data. This gap is problematic as there are numerous clinical conditions (e.g., neuromuscular disease, cancer, glucocorticoid treatment, extreme prematurity) that threaten bone health in this young age group.
The primary goal of our new study is to develop bone mass and density reference data to aid identification of children 1 to 5 years of age with bone deficits. A first step is to characterize the age-related changes in bone accrual at multiple skeletal sites and determine when sex and race differences in bone mass and density emerge.
The second goal of this study is to assess the influence of growth, body composition, gross motor skills and physical activity on bone mineral accrual in young children. In older children, the need to account for growth and lean mass when interpreting bone measurements has been demonstrated. The best way to do this in young children is unknown. Pronounced changes in gross motor skills, locomotion and physical activity also occur during early childhood. It is well appreciated that mechanical loads on the growing skeleton promote bone mineral accrual. but how gross motor skills and physical activity impact bone development in children 1 to 5 years of age is unknown. Understanding the impact of growth, body composition, motor skill development, and physical activity on bone accrual in young children is important for interpretation of clinical bone density measurements. These characteristics are often affected in young children with chronic medical conditions.
This study will enroll 520 healthy children between 1 to 5 years of age; half will be recruited at CCHMC and half at Children's Hospital of Philadelphia.
This study is unique since no previous studies have addressed these issues in children 1-5 y. It is clinically relevant as findings will facilitate medical care of children with chronic medical conditions that threaten bone health, and it will develop and validate novel methods for bone and body composition assessment in this age range. It will also add generalizable knowledge to enhance understanding of the growing skeleton, and its relationship to motor and somatic development. Since poor bone mineral accrual can have lifelong consequences, this study addresses the major public health concern of osteoporosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample
Key inclusion criteria (1 listed)
- We will enroll healthy, normally growing children free from medical conditions that may affect bone or growth between the ages of 1-5 years.
Key exclusion criteria (1 listed)
- Weight, length and weight-for-length outside ± 2 Standard Deviations of the 2006 World Health Organization growth standard for ages 1 to 2 y and the 3rd to 97th percentiles of the Centers for Disease Control 2000 growth reference for ages ≥ 2 years as recommended;84 chronic medical conditions affecting bone density (e.g., cancer, kidney, gastrointestinal, musculoskeletal or endocrine disorder); chronic use of medications that affect bone (glucocorticoids, anti-epileptics, or hormones); prior fracture; dietary restrictions; preterm birth (<37 wk gestation) and low birth weight (<2500 g).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone mineral density
Time frame: Baseline
1 secondary outcome
Bone mineral content
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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.
Heidi Kalkwarf, PhD principal investigator
Cincinnati Children's
Babette Zemel, PhD principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Mineral Density Reference Data, run by Children's Hospital Medical Center, Cincinnati at 2 sites 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone mineral density (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2019.