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Bone LossSTOP-EMNCT05961371

Strength Training for Osteoporosis Prevention During Early Menopause

A study testing Resistance Training in people with Bone Loss and Bone Loss, Age-related, run by University of Calgary at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical pilot trial is to learn about the feasibility of a high-intensity resistance training intervention in peri- and early menopausal females. The main question it aims to answer are: -Is a 9-month resistance training intervention feasible (e.g., recruitment rates, protocol adherence, attrition)… Read more about this study

Who is it for?
Ages 45 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Bone Loss, Bone Loss, Age-related, Osteoporosis
What is being tested?
Resistance Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
1 Nov 2023to Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 45 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 45-60 years old.
  • Menopause status of peri- or early menopausal: stages -2 or -1 of the stages for reproductive aging 10+ staging system or are within 5 years of their last known menses.

Who cannot join

  • Females who are pregnant or planning pregnancy within the next year.
  • Orthopaedic conditions that may be made worse with exercise.
  • Has low back pain, hypertension, lipidemia, diabetes, or cardiovascular disease.
  • Has a history of metabolic bone disease.
  • Has had an osteoporotic fracture within the last 5 years.
  • Had previous treatment with osteoporosis pharmacotherapy.
Show all 9Show fewer
  • Has active glucocorticoid use.
  • Is currently participating in progressive resistance training or has in the previous 6 months.
  • Has low serum vitamin D (25(OH)D) < 30 nmol/L or serum calcium <2.10 mmol/L.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Calgary

    Calgary, Alberta, T2N 1N4

Other trials in Canada

About this study

The goal of this clinical pilot trial is to learn about the feasibility of a high-intensity resistance training intervention in peri- and early menopausal females. The main question it aims to answer are:

-Is a 9-month resistance training intervention feasible (e.g., recruitment rates, protocol adherence, attrition)

Secondary aims include examining changes in bone health, muscle strength, and menopausal symptoms.

Participants will participate in a 9-month progressive, supervised, resistance training intervention. Researchers will compare secondary outcomes between the exercise group and a wait-list control group.

Read the detailed description

The STOP-EM trial will examine a 9-month supervised, progressive, resistance training program in peri- and early menopausal females. Primary outcomes include recruitment rates, protocol adherence, and attrition. A waitlist control group will allow us to examine the effect of the exercise program on bone density, structure, and strength, muscle strength, and menopausal symptoms. Participants will be randomized to the exercise or control group. The exercise group will attend twice weekly, in-person, supervised, progressive resistance training and build up to 80-90% of estimated 1 repetition maximum (1RM). The study will take place at the University of Calgary. Findings will be used to decide whether to continue to the definitive trial.

Keywords
Exercise, Resistance Training, Strength Training
Medical subject headings
Bone Diseases, Metabolic, Osteoporosis, Musculoskeletal Diseases, Motor Activity

What participants receive

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

  • Resistance TrainingOther

    Twice weekly resistance training progressing to 5 sets of 5 repetitions of 80-90% of one repetition maximum.

Study groups in NCT05961371
Study groupRoleWhat they receive
ExerciseExperimentalIn-person, supervised resistance training program
Receives: Other: Resistance Training
ControlNo interventionWaitlist control group. Will be offered the exercise program following a 9-month wait.

What is being measured

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

  1. Feasibility - Recruitment

    Recruitment rates - number of participants recruited per month and number of eligible participants who consented.

    Measured: Over 9 months

  2. Feasibility - Adherence

    Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent.

    Measured: Over 9 months

  3. Feasibility - Attrition

    Attrition (number of randomized participants with valid outcome data) will be expressed as a percent.

    Measured: Over 9 months

Secondary outcomes (19)

  1. Volumetric bone mineral density (BMD)

    High-resolution peripheral quantitative computed tomography (HR-pQCT) will assess total, trabecular, and cortical BMD in mg/cm^3 at the distal tibia and radius.

    Measured: Baseline and 9 months

  2. Bone microarchitecture

    HR-pQCT will assess trabecular thickness and separation and cortical bone thickness in mm at the distal tibia and radius.

    Measured: Baseline and 9 months

  3. Bone strength

    Finite element analysis will be applied to HR-pQCT images at the distal tibia and radius to estimate bone strength (failure load) in N.

    Measured: Baseline and 9 months

  4. areal bone mineral density

    Dual X-ray absorptiometry (DXA) will measure areal bone mineral density (aBMD) in mg/cm^2 for the left hip (total hip and femoral neck), lumbar spine, and whole body.

    Measured: Baseline and 9 months

  5. Muscle strength

    Muscle strength testing will include max voluntary contractions of the knee extensors using an isometric dynamometer. Hand grip strength will be measured using a handgrip dynamometer.

    Measured: Baseline and 9 months

  6. Balance

    The four-square-step test assesses dynamic balance.

    Measured: Baseline and 9 months

  7. Aerobic Fitness

    The 6-minute walk test assesses aerobic fitness

    Measured: Baseline and 9 months

  8. Estrogen concentration

    A blood sample will measure plasma estradiol in pmol/L

    Measured: Baseline and 9 months

  9. Follicle stimulating hormone concentration

    A blood sample will measure plasma follicle stimulating hormone (FSH) in IU/L

    Measured: Baseline and 9 months

  10. Vitamin D concentration

    A blood sample will measure plasma 25-hydroxyvitamin D in nmol/L

    Measured: Baseline and 9 months

  11. Calcium concentration

    A blood sample will measure plasma calcium in mmol/L

    Measured: Baseline and 9 months

  12. Creatinine concentration

    A blood sample will measure plasma creatinine in umol/L

    Measured: Baseline and 9 months

  13. Biomarker of bone resorption

    A blood sample will measure plasma c-telopeptide (CTx) in ng/L

    Measured: Baseline and 9 months

  14. Biomarker of bone formation

    A blood sample will measure plasma procollagen 1 intact N-terminal propeptide (P1NP) in ug/L

    Measured: Baseline and 9 months

  15. Physical activity

    Physical activity will be assessed by wearing an accelerometer for 7 days to assess moderate to vigorous physical activity in minutes per day.

    Measured: Baseline and 9 months

  16. Menopausal quality of life

    Menopausal symptoms will be evaluated through the menopause-specific quality of life questionnaire with a minimum score of 0 and maximum score of 174 and a higher score indicating poorer outcomes

    Measured: Baseline and 9 months

  17. Menopausal symptoms

    Menopausal symptoms will be evaluated through the menopause symptoms treatment satisfaction questionnaire with a minimum score of 0 and maximum score of 40 and a higher score indicating poorer outcomes

    Measured: 9 months

  18. Body mass

    Body mass in kg

    Measured: Baseline and 9 months

  19. Height

    Height in cm

    Measured: Baseline and 9 months

Timeline

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

  1. First posted27 Jul 2023
  2. Study start1 Nov 2023
  3. Primary completionFeb 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized 1:1 to the exercise or waitlist control group.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05961371
Sponsor's protocol ID
REB22-1632
Acronym
STOP-EM
Status last verified
Nov 2024
First submitted
26 Jun 2023
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Watson S, Weeks B, Weis L, Harding A, Horan S, Beck B. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2019 Mar;34(3):572. doi: 10.1002/jbmr.3659. Epub 2019 Feb 25. No abstract available.

    PubMed 30861219

  • Kistler-Fischbacher M, Weeks BK, Beck BR. The effect of exercise intensity on bone in postmenopausal women (part 2): A meta-analysis. Bone. 2021 Feb;143:115697. doi: 10.1016/j.bone.2020.115697. Epub 2020 Dec 24.

    PubMed 33357834

  • Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasibility Stud. 2021 Feb 3;7(1):40. doi: 10.1186/s40814-021-00770-x.

    PubMed 33536076

  • Finkelstein JS, Brockwell SE, Mehta V, Greendale GA, Sowers MR, Ettinger B, Lo JC, Johnston JM, Cauley JA, Danielson ME, Neer RM. Bone mineral density changes during the menopause transition in a multiethnic cohort of women. J Clin Endocrinol Metab. 2008 Mar;93(3):861-8. doi: 10.1210/jc.2007-1876. Epub 2007 Dec 26.

    PubMed 18160467

  • Howe TE, Shea B, Dawson LJ, Downie F, Murray A, Ross C, Harbour RT, Caldwell LM, Creed G. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD000333. doi: 10.1002/14651858.CD000333.pub2.

    PubMed 21735380

  • Watson SL, Weeks BK, Weis LJ, Horan SA, Beck BR. Heavy resistance training is safe and improves bone, function, and stature in postmenopausal women with low to very low bone mass: novel early findings from the LIFTMOR trial. Osteoporos Int. 2015 Dec;26(12):2889-94. doi: 10.1007/s00198-015-3263-2. Epub 2015 Aug 5.

    PubMed 26243363

  • Weeks BK, Beck BR. The BPAQ: a bone-specific physical activity assessment instrument. Osteoporos Int. 2008 Nov;19(11):1567-77. doi: 10.1007/s00198-008-0606-2. Epub 2008 Apr 15.

    PubMed 18414964

  • Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, Sherman S, Sluss PM, de Villiers TJ; STRAW + 10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. J Clin Endocrinol Metab. 2012 Apr;97(4):1159-68. doi: 10.1210/jc.2011-3362. Epub 2012 Feb 16.

    PubMed 22344196

  • Alexander CJ, Kaluta L, Whitman PW, Billington EO, Burt LA, Gabel L. Strength training for osteoporosis prevention during early menopause (STOP-EM): a pilot study protocol for a single centre randomised waitlisted control trial in Canada. BMJ Open. 2025 Feb 5;15(2):e093711. doi: 10.1136/bmjopen-2024-093711.

    PubMed 39909519

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Training in people with Bone Loss and Bone Loss, Age-related, run by University of Calgary at 1 site in Canada.

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 2 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

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?

Feasibility - Recruitment (time frame: Over 9 months). The study lists 3 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 NCT05961371, which also lists 9 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 5 Dec 2024.

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