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Recruiting Phase 2 NCT07191353

Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women

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Trial Parameters

Condition Healthy
Sponsor Odense University Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 148
Sex FEMALE
Min Age 60 Years
Max Age 75 Years
Start Date 2025-10-20
Completion 2027-03-01
Interventions
EverolimusPlaceboResistance training

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Brief 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

Eligibility Criteria

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

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