Actively Recruiting
Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women
Led by Odense University Hospital · Updated on 2026-04-06
148
Participants Needed
2
Research Sites
71 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
B
Bispebjerg Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 60 to 75 years old, any ethnicity
- T-score between -2.5 and -1.0 measured by DXA scan within 6 months before the study start
- Adequate cognitive function to give informed consent
You will not qualify if you...
- Osteoporosis defined as T-score below -2.5 or history of hip or clinical spine fractures
- Low energy fractures within the last 6 months
- Health conditions limiting walking or weight-bearing exercise, such as recent surgery or mobility issues
- Impaired wound healing or chronic open wounds
- Primary hyperparathyroidism
- Known vitamin D deficiency below 25 nM (unless corrected)
- Disorders affecting bone metabolism like uncontrolled thyrotoxicosis, severe kidney or liver impairment, active rheumatic diseases, celiac disease, severe COPD, hypopituitarism, or Cushing's disease
- Use of bone antiresorptive or anabolic drugs within the last 5 years
- Use of anabolic steroids or antiresorptive therapy in the past year
- Use of medications or supplements affecting bone in the past year
- Diabetes type 1 or 2
- Heart failure classified as NYHA Class IV
- Treatment with strong CYP3A4 inhibitors or inducers affecting everolimus metabolism, including specified drugs
- History of coagulopathy or need for long-term anticoagulation
- Blood disorders including anemia, leukopenia, neutropenia, or low platelet count
- Untreated dyslipidemia with high LDL, cholesterol, or triglycerides
- Scheduled immunosuppressant therapy or cancer treatment
- Clinically relevant immune dysfunction or deficiency
- Unstable ischemic heart disease
- Allergy to rapamycin or related drugs
- Inability to speak or understand Danish or cooperate with study procedures
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Institute of Sports Medicine, Bispebjerg Hospital
Bispebjerg, Region Sjælland, Denmark, 2200
Actively Recruiting
2
Department of Endocrinology, Odense University Hospital
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
Research Team
S
Sofie Elkjær, MD
CONTACT
M
Maria Østergaard Madsen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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