CTIS2023-508093-28-00进行中（未招募）1 期
Targeting mTOR with everolimus and/or physical training for preventing postmenopausal bone loss and accelerated skeletal aging. The RapaLoad study. - 2023-508093-28-00
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
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
- 18 至 64（—）
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
研究者
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