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Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women

NCT07191353 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2026-04-06

No results posted yet for this study

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

  • Healthy
  • Osteopenia
  • Osteoporosis Risk

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

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Moustapha Kassem, MD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2027-03-01
Completion
2027-03-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191353 on ClinicalTrials.gov