Healthy study: Everolimus
Official title Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women
ClinicalTrials.gov ID: NCT07191353
What this study is testing
What is Everolimus?
An investigational once‑weekly oral medicine being studied for improving bone and muscle health in elderly women. is designed to inhibit the mTOR pathway, which may influence cell growth and metabolism.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether everolimus, resistance training, or their combination can increase bone formation and muscle function compared with no treatment.
- Who it's for
- Women aged 60 to 75 who are healthy or at risk for low bone density.
- What's involved
- Participants will take a weekly pill (everolimus or placebo) and may do one‑hour resistance training three times a week. They will have 5‑7 visits for blood tests, bone scans, muscle and bone biopsies, questionnaires, and muscle function tests.
- Time commitment
- The study lasts about 6 months and requires 5‑7 clinic visits, plus weekly exercise sessions if assigned to training.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 75, women only. Healthy volunteers may be eligible.
You may be able to join if
- Women aged 60-75 years old, any ethnicity.
- Participants with T- score between \ -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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Women aged 60-75 years old, any ethnicity.
- Participants with T- score between \ -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.
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Bispebjerg, Region Sjælland, Denmark
- Odense, Region Syddanmark, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 60 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bispebjerg, Region Sjælland, Denmark; Odense, Region Syddanmark, Denmark. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.