Osteoporosis Clinical Trials

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Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 60
Maximum Age: 75
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Denmark
Institute of Sports Medicine, Bispebjerg Hospital
RECRUITING
Bispebjerg
Department of Endocrinology, Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Sofie Elkjær, MD
anna.sofie.elkjaer3@rsyd.dk
+4521428178
Backup
Maria Østergaard Madsen, MD
frederik.marquard.nielsen@regionh.dk
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 148
Treatments
Experimental: Everolimus
Oral everolimus 5 mg once a week
Experimental: Everolimus and resistance training
Oral everolimus 5 mg once a week plus resistance training RT 1 hour, 3 times weekly
Placebo_comparator: Placebo
Oral placebo once a week
Placebo_comparator: Placebo and resistance training
Oral placebo once a week plus resistance training RT 1 hour, 3 times weekly
Sponsors
Collaborators: Bispebjerg Hospital
Leads: Odense University Hospital

This content was sourced from clinicaltrials.gov