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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women

Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women (NCT07191353) is a Phase 2 interventional studying Healthy and Osteopenia, sponsored by Odense University Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Healthy and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 148 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Healthy subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Everolimus

Everolimus 5 mg administered once weekly for 24 weeks

DRUG

Placebo

Placebo administered once weekly for 24 weeks

OTHER

Resistance training

Resistance training 3 times a week for 24 weeks

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Institute of Sports Medicine, Bispebjerg Hospital
Bispebjerg, Region Sjælland, Denmark
Department of Endocrinology, Odense University Hospital
Odense, Region Syddanmark, Denmark

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07191353), the sponsor (Odense University Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07191353 clinical trial studying?

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 plu… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07191353?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07191353?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07191353. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07191353. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.