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RECRUITING
NCT07191353
PHASE2

Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

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

Key Details

Gender

FEMALE

Age Range

60 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2025-10-20

Completion Date

2027-03-01

Last Updated

2026-04-06

Healthy Volunteers

Yes

Interventions

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

Locations (2)

Institute of Sports Medicine, Bispebjerg Hospital

Bispebjerg, Region Sjælland, Denmark

Department of Endocrinology, Odense University Hospital

Odense, Region Syddanmark, Denmark