NCT02946424Unknown2 期
Simvastatin to Improve Bone Health in SCI: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in knee bone mineral density
研究概览
简要总结
This is a double blind, randomized, placebo -controlled clinical trial with the primary goal of determining the osteogenic benefits of simvastatin in acute SCI.
详细描述
Investigators will test if a 1- year course of simvastatin (40 mg daily) will prevent bone loss compared to placebo in the first year following SCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age
- •acute SCI (AIS A-C) who are enrolled at our center in an ongoing surveillance study.
- •use a wheelchair as their primary mobility mode
- •reside in the greater Denver metropolitan area
- •within 3 months of injury
- •medically stable
- •able to follow directions
- •provide informed consent.
排除标准
- •have any simvastatin contraindications including:
- •drug allergy,
- •active liver disease,
- •renal dysfunction,
- •concurrent use of drugs that cause myopathy or increase the risk of myopathy with simvastatin therapy (gemfibrozil, niacin, cyclosporine, danazol, amiodarone, dronedarone, ranolazine, calcium channel blockers, colchicine), strong CYP34A inhibitors (itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, cobicistat-containing products), low plasma cholesterol levels,
- •uncontrolled or poorly controlled diabetes,
- •unstable anti-coagulation treatment,
- •taking a statin in the preceding 12 months,
- •metabolic bone disease, thyroid disorder,
- •history of bilateral oophorectomy,
- •current use of medications potentially affecting bone health including bisphosphonates, androgenic steroids, estrogenic steroids, anti-epileptics, lithium glucocorticoid use for more than 3 months,
- •have received inhaled glucocorticoids in the past 12 months,
- •pregnant or lactating women,
- •women of childbearing potential who are unwilling or unable to use a reliable form of contraception.
研究组 & 干预措施
Simvastatin treatment
Experimental
Simvastatin for one year time period
干预措施: Simvastatin (Drug)
Placebo treatment
Placebo Comparator
Placebo for one year time period
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Change in knee bone mineral density
时间窗: baseline and 12 months
assessed by DXA
次要结局
- Change in mood(baseline and 12 months)
- Change in pain(baseline and 12 months)
- Satisfaction with life(baseline and 12 months)
- Change in bone volume(baseline and 12 months)
- Change in community reintegration(baseline and 12 months)
- Change in motor score(baseline and 12 months)
- Change in tibial bone strength(baseline and 12 months)
研究者
Leslie Morse
Principal Investigator
Craig Hospital
研究点 (1)
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