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Recruiting NCT07191353

Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women

Phase II Interventional Healthy Osteopenia Osteoporosis Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Everolimus, Placebo, Resistance training.
Who it may be relevant to
Registry conditions: Healthy, Osteopenia, Osteoporosis Risk. Basic parameters: 60 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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

Primary outcome measures

  • P1NP [Time frame: From baseline to end of treatment at 24 weeks]
Secondary outcome measures (12)
  • Bone resorption markers [Time frame: From baseline to end of treatment 24 weeks]
  • BMD [Time frame: From screening to end of treatment 24 weeks]
  • Bone mass [Time frame: From baseline to end of treatment 24 weeks]
  • Bone microarchitecture [Time frame: From baseline to end of treatment 24 weeks]
  • Bone geometry [Time frame: From baseline to end of treatment (24 weeks)]
  • Muscle Cross-Sectional Area [Time frame: From baseline to end of treatment 24 weeks]
  • Muscle assessment [Time frame: From baseline to end of treatment 24 weeks]
  • Metabolic health (test 1) [Time frame: From baseline to end of treatment 24 weeks]
  • Quality of life quiestionaire [Time frame: From baseline to end of treatment 24 weeks]
  • Muscle function (power) [Time frame: From baseline to end of treatment 24 weeks.]
  • Bone formation markers [Time frame: From baseline to end of study 24 weeks]
  • Metabolic health (test 2) [Time frame: From screening to end of treatment 24 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 2 centers
  • Institute of Sports Medicine, Bispebjerg Hospital — Bispebjerg
  • Department of Endocrinology, Odense University Hospital — Odense

Identifiers

NCT: NCT07191353 · 2024-520372-10-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗