Repurposing Everolimus to enhance musculoskeletal Vitality and Ageing in The Elderly (RENOVATE)

Phase 1

• Conditions: General healthy elderly with stable medical conditions; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2023-509838-19-00
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Men and women aged 65-85 years old, any ethnicity, Be in relatively good general health,(with only well-managed chronic diseases (hypertension, coronary artery disease, etc.), clinically stable, Participants without health conditions that could limit walking (for instance recent injury)

Exclusion Criteria

Diabetes type 1 and 2, 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 immunsuppresant 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, Heart failure similar to NYHA Class IV, 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 <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, Inability to give informed consent, Treatment with drugs known to affect cytochrome P450 3A due to its role in rapamycin metabolism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified