2023-508093-28-00招募中2 期
Targeting mTOR with everolimus and/or physical training for preventing postmenopausal bone loss and accelerated skeletal aging. The RapaLoad study.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- - Percentage change in circulating levels of bone formation marker N-terminal fragment of procollagen type 1 (P1NP) at 24 weeks as compared with baseline.
研究概览
简要总结
This study aims to determine if treatment with everolimus, exercise training, or their combination for 24 weeks enhances bone formation in healthy postmenopausal women.
研究设计
- 分配方式
- Randomized
- 主要目的
- Rapa Load
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Diabetes (type 1 and 2)
- •Patients with impaired wound healing or history of a chronic open wound
- •Scheduled for immunosuppressant therapy for transplant or scheduled to undergo chemother-apy or any other treatment for malignancy
- •Untreated dyslipidemia with LDL-c > 4.9 mmol/L and family history of dyslipidemia, Total cho-lesterol > 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 ina-bility to cooperate or perform physical training
- •Inability to give informed consent
- •Heart failure similar to NYHA Class IV
- •Primary hyperparathyroidism
- •Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal im-pairment (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 metab-olism
- •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 abso-lute neutrophil count < 2,000/mm3, or Platelet count – platelet count < 125,000/mm3
结局指标
主要结局
- Percentage change in circulating levels of bone formation marker N-terminal fragment of procollagen type 1 (P1NP) at 24 weeks as compared with baseline.
- Percentage change in circulating levels of bone formation marker N-terminal fragment of procollagen type 1 (P1NP) at 24 weeks as compared with baseline.
次要结局
- - Change in circulating levels of bone turnover markers: 1)Bone resorption markers (C-terminal telopeptide of type 1 collagen (CTX) and Tartrate resistant acid phosphatase (TRAcP)) at baseline, 4, 12 and 24 weeks. 2) Bone formation markers (osteocalcin, and bone alkaline phosphatase) at baseline, 4, 12 and 24 weeks and P1NP at 4 and 12weeks
- - Lumbar spine (L1-4), and total hip and femoral neck bone mineral density (BMD) meas-ured by dual-energy X-ray absorptiometry (DXA) at baseline and 24 weeks
- - Bone microarchitecture, mass, and geometry at the distal radius and tibia assessed us-ing high-resolution peripheral quantitative computed tomography (HR-pQCT) at base-line and 24 weeks
- - Muscle function and postural balances tested at base-line and 24 weeks
- - Cardiopulmonary health estimated by measuring Vo2max at baseline and week 24.
- - Metabolic health: weight, body composition by DXA scanning, fasting blood glucose, fasting insulin, lipid parameters and metabolomic studies at baseline and week 24.
研究者
Florence Figeac
Scientific
Odense University Hospital
研究点 (1)
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