Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women (NCT07191353) | Clinical Trial Compass
RecruitingPhase 2
Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women
Denmark148 participantsStarted 2025-10-20
Plain-language summary
The aim of the present clinical trial is to examine the effects of everolimus, resistance training, or their combination on bone and muscle health formation in elderly women aged 60-75 years. The main questions it aims to answer are:
Can rapamycin's analog (Everolimus), resistance training, or their combination, enhance bone formation and muscle functions in elderly women compared to non-treatment controls.
Participants will be randomized 1:1:1:1 to one of the following treatment regimens:
* Oral everolimus 5 mg once a week.
* Oral placebo once a week.
* Oral everolimus 5 mg once a week plus resistance training RT 1 hour, 3 times weekly.
* Oral placebo once a week plus resistance training RT 1 hour, 3 times weekly.
During the study there will be a total of 5-7 visits, where the participants will undergo the following:
* Blood samles
* DXA-, HRpQCT- (only Odense Universitetshospital) and MRI-scans
* Muscle- and bone biopsies
* Quality of life questionnaires
* Testing of muscle funtion
* Metabolic studies of muscle and bone protein turnover using labelling with deuturated water
Who can participate
Age range
60 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women aged 60-75 years old, any ethnicity.
* Participants with T- score between \< 1.0 and \> -2.5 measured by DXA scan within 6 months of the first day of the study.
* Adequate cognitive function to be able to give informed consent.
Exclusion Criteria:
* Osteoporosis and fracture history
* Participants with osteoporosis (defined by DXA scan \< 6 months old: low bone mass, T-score \< -2.5 or hip fracture or clinical compression fracture of the spine).
* History of low energy fractures within last 6 months. Health conditions limiting exercise
* Health conditions that could limit walking and weightbearing exercise (for instance recent surgery, mobility limitation)
* Participants with impaired wound healing or history of a chronic open wound Bone metabolism disorders
* Primary hyperparathyroidism.
* Known vitamin D deficiency (\<25 nM) (re-test after substitution acceptable).
* Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR \< 30) or impaired liver function (baseline phosphatase higher than twice upper limit (105 U/L)), active rheumatic diseases, celiac disease, severe chronic obstructive lung disease (COPD), hypopituitarism, or Cushing's disease.
* Previous use of bone antiresorptive or bone anabolic drugs within the last 5 years.
Medication use and health conditions
* Use of anabolic steroids in the previous year.
* Use of antiresorptive therapy in the previous year.
* Know…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
P1NP
Timeframe: From baseline to end of treatment at 24 weeks