Using Everolimus and exercise to prevent bone loss in postmenopausal women
Targeting mTOR With Everolimus and/or Physical Training for Preventing Postmenopausal Bone Loss and Accelerated Skeletal Aging: The RapaLoad Study
This study is testing whether the drug Everolimus and a structured exercise program can help prevent bone loss in postmenopausal women aged 45-60.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 45 Years to 60 Years |
| Sex | Female |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Odense and 1 other locations) |
| Trial ID | NCT06789900 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Everolimus, an mTOR inhibitor, and a structured exercise program on preventing bone loss in postmenopausal women aged 45-60. The study aims to address the significant bone mass loss that occurs during the postmenopausal transition, which can lead to osteoporotic fractures. Participants will be randomized to receive either Everolimus, exercise, or a combination of both to evaluate their effectiveness in maintaining bone density. The trial seeks to provide an alternative to hormone replacement therapy, which is often not preferred due to potential side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 45-60 who have not experienced low energy fractures in the past six months.
Not a fit: Patients with diabetes, severe heart failure, or known disorders affecting bone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new preventive strategy against bone loss for postmenopausal women, reducing the risk of fractures.
How similar studies have performed: While the use of mTOR inhibitors like Everolimus is established in other contexts, this specific approach combining it with exercise in postmenopausal women is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenopausal women aged 45-60 years old as evidenced by measuring serum levels of LH and FSH and absence of menstruation for at least 1 year. * No history of low energy hip or vertebral fractures during the last 6 months. * Ability to provide informed consent. Exclusion Criteria: * Diabetes (type 1 and 2) * Heart failure similar to NYHA Class IV * Primary hyperparathyroidism * Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR \<20) or 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. * Use of anabolic steroids in the previous year * Treatment with drugs known to affect cytochrome P450 3A due to its role in everolimus metabolism * History of coagulopathy or medical condition requiring long-term anticoagulation * Anemia - Hg \< 9.0 g/dl, Leukopenia - white blood cells (WBC) \< 3,500/mm3, Neutropenia absolute neutrophil count \< 2,000/mm3, or Platelet count - platelet count \< 125,000/mm3 * Patients with impaired wound healing or history of a chronic open wound * Scheduled for immunosuppressant therapy for transplant or scheduled to undergo chemotherapy or any other treatment for malignancy * Untreated 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 * Any form of clinically relevant primary or secondary immune dysfunction or deficiency * Unstable ischemic heart disease * Bone mineral density (BMD) measured by DXA scanning with T-score \<-3 * Known allergy to rapamycin or rapalogs * The study will exclude participants with inability to speak and understand Danish and with inability to cooperate or perform physical training. * Inability to give informed consent
Where this trial is running
Odense and 1 other locations
- Odense University Hospital — Odense, Denmark (Not_yet_recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Moustapha Kassem, DMSc, PhD — Odense University Hospital
- Study coordinator: Sofie Damkjær, MD
- Email: sofie.damkjaer.hansen@rsyd.dk
- Phone: +4520575198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.