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NCT07191353: StrongBone
Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women
Phase 2 trial testing Everolimus in Healthy in 148 participants. Currently enrolling.
1 March 2027
Quick facts
| Lead sponsor | Odense University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 148 |
| Start date | 20 October 2025 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 March 2027 |
| Sites | 2 locations across Denmark |
Drugs / interventions tested
- Everolimus (everolimus) — full drug profile →
- Placebo
- Resistance training
Conditions studied
- Healthy — all drugs for Healthy →
- Osteopenia — all drugs for Osteopenia →
- Osteoporosis Risk — all drugs for Osteoporosis Risk →
Sponsor
Odense University Hospital
Who can join
Adults 60 to 75, female only, with Healthy or Osteopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07191353
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07191353 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Odense University Hospital
- Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07191353.
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