Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age60-75
SponsorOdense University Hospital
About this trial
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 criteria
Qualifiers
Women aged 60-75 years old, any ethnicity.
Participants with T- score between < 1.0 and > -2.5 measured by DXA scan within 6 months of the first day of the study.
Adequate cognitive function to be able to give informed consent.
Disqualifiers
Osteoporosis and fracture history
Participants with osteoporosis (defined by DXA scan < 6 months old: low bone mass, T-score < -2.5 or hip fracture or clinical compression fracture of the spine).
History of low energy fractures within last 6 months. Health conditions limiting exercise
Health conditions that could limit walking and weightbearing exercise (for instance recent surgery, mobility limitation)
Trial design
Treatments tested in this trial
- Everolimus
- Placebo
- Resistance training
Treatment groups
148 Participants
are divided into 4 treatment groupsSponsors and collaborators
Odense University Hospital
Lead sponsor
Bispebjerg Hospital
Collaborator
Source ClinicalTrials.gov