Everolimus and/or Exercise to Prevent Bone Loss in Postmenopausal Women

Launched by ODENSE UNIVERSITY HOSPITAL · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether the drug Everolimus, exercise, or a combination of both can help prevent bone loss in postmenopausal women. During the years after menopause, women can lose a significant amount of bone mass, which increases the risk of fractures. The trial will involve 136 women aged 45 to 60 who have not had any recent bone fractures. Participants will be divided into different groups to either receive general health advice, participate in exercise sessions based on a football fitness concept, take Everolimus, or both exercise and take the drug.

Eligible women for this study must be postmenopausal (meaning they have not had a menstrual period for at least a year) and not have a history of certain bone fractures in the last six months. Throughout the 24-week trial, participants will undergo assessments to measure changes in bone health and muscle function. This research aims to find out if Everolimus and exercise can improve bone strength and overall physical health in women during this important transition in life.

Gender

FEMALE

Eligibility 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