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
| Type | Name | Description |
|---|---|---|
| DRUG | Everolimus | Everolimus 5 mg administered once weekly for 24 weeks |
| DRUG | Placebo | Placebo administered once weekly for 24 weeks |
| OTHER | Resistance training | Resistance 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.