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

Odense University Hospital0 个研究点目标入组 120 人开始时间: 2023年12月20日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Odense University Hospital
入组人数: 120

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 65 至 65+（—）
性别: All

入选标准

•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)

排除标准

•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

研究者

发起方

Odense University Hospital

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