2024-520372-10-00招募中2 期
Resistance training and rapamycin to enhance bone formation in postmenopausal women (STRONGBONE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 2
- 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
To investigate if treatment with everolimus (rapamycin analog), exercise training, or their combination for 24 weeks enhances bone formation in healthy postmenopausal women.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 60-75 years old, any ethnicity
- •Participants with T- score between < 1.0 and > -2.5 measured by DXA scan within 6 months of the first day of the study
- •Adequate cognitive function to be able to give informed consent
排除标准
- •Diabetes type 1 and 2
- •Participants with osteoporosis (defined by DXA scan < 6 months old: low bone mass, T-score < -2.5 or hip fracture or clinical compression fracture of the spine)
- •The study will exclude participants with inability to speak and understand Danish and with inability to cooperate
- •Known allergy to rapamycin or rapalogs
- •History of low energy fractures within last 6 months
- •Health conditions that could limit walking and weightbearing exercise (for instance recent surgery, mobility limitation)
- •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 <30) or impaired 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
- •Treatment with drugs known to affect cytochrome P450 3A due to its role in everolimus metabolism, excluding strong CYP3A4 inhibitors or inducers, while allowing weak and intermediate inhibitors or inducers. For instance Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Telithromycin, Clarithromycin, Nedazodone, Ritonavir, Atazanavir, Saquinavir, Darunavir, Indinavir, Nelfinavir, Rifampicin, Dexamethasone, Carbamazepine, phenobarbital, Phenytoin, Efavirenz and Nivirapine.
- •Use of anabolic steroids in the previous year
- •Use of antiresorptive therapy in the previous year
- •Known medication/supplements affecting bone in the previous year
- •History of coagulopathy or medical condition requiring long-term anticoagulation
- •Insufficiently treated 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
- •Anemia – Hg < 5,59 mmol/L, Leukopenia – white blood cells (WBC) < 3,5 x 10⁹/L, Neutropenia absolute neutrophil count < 2,0 x 10⁹/L, or Platelet count – platelet count < 125 x 10⁹/L
- •Participants with impaired wound healing or history of a chronic open wound
- •Scheduled for immunosuppressant therapy for transplant or scheduled to undergo chemotherapy or any other treatment for malignancy
- •Any form of clinically relevant primary or secondary immune dysfunction or deficiency
- •Unstable ischemic heart disease
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 marker: C-terminal telopeptide of type 1 collagen (CTX) at baseline and 24 weeks
- Changes in areal BMD at the lumbar spine (L1-4), total hip and femoral neck measured by dual energy x-ray absorptiometry DXA at baseline and 24 weeks
- Changes in volumetric BMD, mass, bone microstructures and estimated strength at distal tibia and radius assessed using high resolution peripheral quantitative computed tomography (HRpQCT) at baseline and 24 weeks
- Changes in muscle function, power and strength for upper and lower extremities will be assessed using
- Changes in health-related quality of life assessment (SF-12 questionnaire)
研究者
Anna Sofie Elkjær
Scientific
Odense University Hospital
研究点 (2)
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