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HealthyPhase 2StrongBoneNCT07191353

Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women

A Phase 2 study testing Everolimus and Resistance training in people with Healthy and Osteopenia, run by Odense University Hospital at 2 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy, Osteopenia, Osteoporosis Risk
What is being tested?
Everolimus and Resistance training
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
148 participants
Where
2 sitesDenmark
Study dates
20 Oct 2025to 1 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
  • Participants with impaired wound healing or history of a chronic open wound Bone metabolism disorders
  • Primary hyperparathyroidism.
Show all 27Show fewer
  • Known vitamin D deficiency (<25 nM) (re-test after substitution acceptable).
  • 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.
  • Previous use of bone antiresorptive or bone anabolic drugs within the last 5 years.
  • Medication use and health conditions
  • Use of anabolic steroids in the previous year.
  • Use of antiresorptive therapy in the previous year.
  • Known medication/supplements affecting bone in the previous year.
  • Diabetes type 1 and 2.
  • Heart failure similar to NYHA Class IV.
  • 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. Patients on the following drugs will be excluded from the trial: Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Telithromycin, Clarithromycin, Nedazodone, Ritonavir, Atazanavir, Saquinavir, Darunavir, Indinavir, Nelfinavir, Rifampicin, Dexamethasone, Carbamazepine, phenobarbital, Phenytoin, Efavirenz and Nivirapine.
  • History of coagulopathy or medical condition requiring long-term anticoagulation.
  • Blood disorders and other health concerns
  • 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.
  • 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.
  • Immunosuppressive and current cancer Treatment
  • Scheduled for immunosuppressant therapy for transplant or scheduled to undergo chemotherapy or any other treatment for malignancy
  • Any form of clinically relevant primary or secondary immune dysfunction or deficiency Cardiovascular and heart conditions
  • Unstable ischemic heart disease.
  • Allergies
  • Known allergy to rapamycin or rapalogs. Language limitations
  • The study will exclude participants with inability to speak and understand Danish and with inability to cooperate.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sofie Elkjær, MD contact

+4521428178

anna.sofie.elkjaer3@rsyd.dk

Maria Østergaard Madsen, MD contact

frederik.marquard.nielsen@regionh.dk

Denmark2 sites, 2 recruiting

  • Institute of Sports Medicine, Bispebjerg Hospital

    Bispebjerg, Region Sjælland, 2200

    Frederik M Nielsen, Doctor, 42802315, frederik.marquard.nielsen@regionh.dk

    Abigail Mackey, Professor, abigailmac@sund.ku.dk

    Recruiting

  • Department of Endocrinology, Odense University Hospital

    Odense, Region Syddanmark, 5000

    Sofie Elkjær, MD, +4521428178, anna.sofie.elkjaer3@rsyd.dk

    Moustapha Kassem, MD, professor, +45 24467199, mkassem@health.sdu.dk

    Recruiting

Other trials in Denmark

About this study

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.

Read more

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
Being tested
Everolimus, Placebo, Resistance training
Keywords
Postmenopausal Women, Rapamycin, Bone formation, Muscle functions, Healthy aging
Medical subject headings
Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

    Everolimus 5 mg administered once weekly for 24 weeks

  • PlaceboDrug

    Placebo administered once weekly for 24 weeks

  • Resistance trainingOther

    Resistance training 3 times a week for 24 weeks

Study groups in NCT07191353
Study groupRoleWhat they receive
EverolimusExperimentalOral everolimus 5 mg once a week
Receives: Drug: Everolimus
Everolimus and resistance trainingExperimentalOral everolimus 5 mg once a week plus resistance training RT 1 hour, 3 times weekly
Receives: Drug: Everolimus; Other: Resistance training
PlaceboPlacebo comparatorOral placebo once a week
Receives: Drug: Placebo
Placebo and resistance trainingPlacebo comparatorOral placebo once a week plus resistance training RT 1 hour, 3 times weekly
Receives: Drug: Placebo; Other: Resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. P1NP

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

    Measured: From baseline to end of treatment at 24 weeks

Secondary outcomes (15)

  1. Bone resorption markers

    Change in bone resorption markers (C-terminal telopeptide of type 1 collagen (CTX) at baseline, 4, 12 and 24 weeks.

    Measured: From baseline to end of treatment 24 weeks

  2. BMD

    Lumbar spine (L1-4), and total hip and femoral neck bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) at screening visit/baseline, and 24 weeks.

    Measured: From screening to end of treatment 24 weeks

  3. Bone mass

    Bone mass at the distal radius and tibia measured using high-resolution peripheral quantitative computed tomography (HR-pQCT) at baseline, and 24 weeks.

    Measured: From baseline to end of treatment 24 weeks

  4. Bone microarchitecture

    Bone microarchitecture at the distal radius and tibia measured using high-resolution peripheral quantitative computed tomography (HR-pQCT) at baseline, and 24 weeks.

    Measured: From baseline to end of treatment 24 weeks

  5. Bone geometry

    Bone geometry at the distal radius and tibia measured using high-resolution peripheral quantitative computed tomography (HR-pQCT) at baseline and 24 weeks.

    Measured: From baseline to end of treatment (24 weeks)

  6. Muscle Cross-Sectional Area

    Muscle Cross-Sectional Area (CSA) measured by Magnetic Resonance Imaging (MRI) at baseline, 12, and 24 weeks.

    Measured: From baseline to end of treatment 24 weeks

  7. Muscle assessment

    Change in muscle strength for the lower extremities, measured using a isokinetic dynamometry at baseline, midway and week 24.

    Measured: From baseline to end of treatment 24 weeks

  8. Metabolic health (test 1)

    Body weight measured by a digital scale at baseline, 4, 12, and 24 weeks.

    Measured: From baseline to end of treatment 24 weeks

  9. Quality of life quiestionaire

    Quality of life (QoL)questionnaire SF-12 questionnaire (including mental QoL and physical QoL, and various health and possible side effects) at baseline and 24 weeks

    Measured: From baseline to end of treatment 24 weeks

  10. Muscle function (power)

    Muscle function (power) using the 30-second sit-to-stand test (RSS) at baseline, midway and week 24.

    Measured: From baseline to end of treatment 24 weeks.

  11. Bone formation markers

    P1NP at baseline, 4 and 12 and 24 weeks.

    Measured: From baseline to end of study 24 weeks

  12. Metabolic health (test 2)

    Total body fat percentage assessed by dual-energy X-ray absorptiometry (DXA), at screening and 24 weeks.

    Measured: From screening to end of treatment 24 weeks

  13. Metabolic health (test 3)

    Lipid parameters (LDL, HDL, Triglycerides, Cholesterol) at baseline, 4, 12, and 24 weeks

    Measured: From baseline to end of treatment 24 weeks

  14. Metabolic Health (Test 4)

    Total lean mass assessed by dual-energy X-ray absorptiometry (DXA) screening and baseline, and 24 weeks.

    Measured: From screening to end treatment

  15. Metabolic health (test 5)

    Bone mineral density assessed by dual-energy X-ray absorptiometry (DXA) at screening and 24 weeks.

    Measured: From screening to end of treatment 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start20 Oct 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 2, two-parallel, randomized, placebo-controlled clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07191353
Sponsor's protocol ID
2024-520372-10-00
Acronym
StrongBone
Status last verified
Mar 2026
First submitted
9 Sep 2025
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus and Resistance training in people with Healthy and Osteopenia, run by Odense University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sofie Elkjær, MD (+4521428178, anna.sofie.elkjaer3@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

P1NP (time frame: From baseline to end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07191353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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