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Trials / Recruiting

RecruitingNCT07191353

Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
148 (estimated)
Sponsor
Odense University Hospital · Academic / Other
Sex
Female
Age
60 Years – 75 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DRUGEverolimusEverolimus 5 mg administered once weekly for 24 weeks
DRUGPlaceboPlacebo administered once weekly for 24 weeks
OTHERResistance trainingResistance training 3 times a week for 24 weeks

Timeline

Start date
2025-10-20
Primary completion
2027-03-01
Completion
2027-03-01
First posted
2025-09-24
Last updated
2026-04-06

Locations

2 sites across 1 country: Denmark

Source: ClinicalTrials.gov record NCT07191353. Inclusion in this directory is not an endorsement.