2023-509838-19-00招募中2 期
Repurposing Everolimus to enhance musculoskeletal Vitality and Ageing in The Elderly (RENOVATE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in serum bone formation marker P1NP
研究概览
简要总结
To investigate if everolimus (rapamycin analog) prevents age-related bone loss by enhancing bone formation and improving muscle functions and reducing the burden of biological mechanisms of aging in elderly persons.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
Changes in serum bone formation marker P1NP
Changes in serum bone formation marker P1NP
次要结局
- Changes in serum bone resorption marker CTX
- Changes in areal BMD at the lumbar spine, total hip and femoral neck measured by DXA scanning
- Changes in volumetric BMD, bone microstructures and estimated strength at distal tibia and radius (HRpQT)
- Changes in muscle function, power and strength for upper and lower extremities will be assessed using a standard hydraulic hand dynamometer, the 30-second sit-to-stand test (RSS), respectively and gait speed.
- Changes in health-related quality of life assessment (SF-12 questionnaire)
研究者
Moustapha Kassem
Scientific
Odense University Hospital
研究点 (1)
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