Can a weekly pill and weight lifting rebuild aging bones?
NCT ID NCT07191353
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a weekly dose of everolimus (a drug similar to rapamycin), resistance training three times a week, or both together can improve bone formation in women aged 60-75 with low bone mass. Researchers will measure bone markers, density, and muscle function over 24 weeks. The goal is to find a safe way to prevent osteoporosis without long-term medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Everolimus (a rapamycin analog) and resistance training
- What this could lead to
- If successful, this could point toward a drug-exercise combination to strengthen bones and reduce fracture risk in older women.
- What could go wrong
- This is a small, early-phase trial with 148 participants. The drug may cause side effects, and results may not apply to all women. The combination might not work better than exercise alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Endocrinology, Odense University Hospital
RECRUITINGOdense, Region Syddanmark, 5000, Denmark
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Institute of Sports Medicine, Bispebjerg Hospital
RECRUITINGBispebjerg, Region Sjælland, 2200, Denmark
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