Resistance training and rapamycin to enhance bone formation in postmenopausal women (STRONGBONE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Healthy volunteers

Age range

65+ years

Gender

Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

8 Oct 2025 → ongoing

Decision date (initial)

2025-07-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

NovoNordisk Foundation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To investigate if treatment with everolimus (rapamycin analog), exercise training, or their combination for 24 weeks enhances bone formation in healthy postmenopausal women.

Conditions and MedDRA coding

General healthy elderly women with stable medical conditions

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Women aged 60-75 years old, any ethnicity
2. Participants with T- score between < 1.0 and > -2.5 measured by DXA scan within 6 months of the first day of the study
3. Adequate cognitive function to be able to give informed consent
4. Must be able to complete 3 weekly training sessions in addition to the current training routines, without changing prior training volume or intensity

Exclusion criteria 21

1. Diabetes type 1 and 2
2. 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)
3. The study will exclude participants with inability to speak and understand Danish and with inability to cooperate
4. Known allergy to rapamycin or rapalogs
5. History of low energy fractures within last 6 months
6. Health conditions that could limit walking and weightbearing exercise (for instance recent surgery, mobility limitation)
7. Heart failure similar to NYHA Class IV
8. Primary hyperparathyroidism
9. Known vitamin D deficiency (<25 nM) (re-test after substitution acceptable)
10. Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR <30) or impaired liver function (baseline phosphatase higher than twice upper limit (105 U/L)), active rheumatic diseases, celiac disease, severe chronic obstructive lung disease (COPD), hypopituitarism, or Cushing’s disease.
11. Previous use of bone antiresorptive or bone anabolic drugs within the last 5 years
12. Treatment with drugs known to affect cytochrome P450 3A due to its role in everolimus metabolism, excluding strong CYP3A4 inhibitors or inducers, while allowing weak and intermediate inhibitors or inducers. For instance Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Telithromycin, Clarithromycin, Nedazodone, Ritonavir, Atazanavir, Saquinavir, Darunavir, Indinavir, Nelfinavir, Rifampicin, Dexamethasone, Carbamazepine, phenobarbital, Phenytoin, Efavirenz and Nivirapine.
13. Known medication affecting bone in the previous year
14. History of coagulopathy or medical condition requiring long-term anticoagulation
15. Insufficiently treated dyslipidemia with LDL-c > 4,9 mmol/L and family history of dyslipidemia, Total cholesterol > 9,1 mmol/L, or triglycerides > 9,9 mmol/L
16. Anemia – Hg < 5,59 mmol/L, Leukopenia – white blood cells (WBC) < 3,5 x 10⁹/L, Neutropenia absolute neutrophil count < 2,0 x 10⁹/L, or Platelet count – platelet count < 125 x 10⁹/L
17. Participants with impaired wound healing or history of a chronic open wound
18. Scheduled for immunosuppressant therapy for transplant or scheduled to undergo chemotherapy or any other treatment for malignancy
19. Any form of clinically relevant primary or secondary immune dysfunction or deficiency
20. Unstable ischemic heart disease
21. A potential participant should not be included if they prior to enrollment do structured strength training weekly within the past 6 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage change in circulating levels of bone formation marker N-terminal fragment of procollagen type 1 (P1NP) at 24 weeks as compared with baseline

Secondary endpoints 5

1. Change in circulating levels of bone turnover marker: C-terminal telopeptide of type 1 collagen (CTX) at baseline and 24 weeks
2. Changes in areal BMD at the lumbar spine (L1-4), total hip and femoral neck measured by dual energy x-ray absorptiometry DXA at baseline and 24 weeks
3. Changes in volumetric BMD, mass, bone microstructures and estimated strength at distal tibia and radius assessed using high resolution peripheral quantitative computed tomography (HRpQCT) at baseline and 24 weeks
4. Changes in muscle function, power and strength for upper and lower extremities will be assessed using
5. Changes in health-related quality of life assessment (SF-12 questionnaire)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J B Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

Anna Sofie Elkjær

Public contact point

Organisation

Odense University Hospital

Contact name

Anna Sofie Elkjær

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 34 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications