RecruitingPhase 2NCT07191353

Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women


Sponsor

Odense University Hospital

Enrollment

148 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 60 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Everolimus, a drug called Placebo, and others for people with healthy, osteopenia, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEverolimus

Everolimus 5 mg administered once weekly for 24 weeks

DRUGPlacebo

Placebo administered once weekly for 24 weeks

OTHERResistance training

Resistance training 3 times a week for 24 weeks


Locations(2)

Institute of Sports Medicine, Bispebjerg Hospital

Bispebjerg, Region Sjælland, Denmark

Department of Endocrinology, Odense University Hospital

Odense, Region Syddanmark, Denmark

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NCT07191353


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