NCT00150696已完成3 期
Risedronate for Prevention of Osteoporosis After Spinal Cord Injury
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.
研究概览
简要总结
The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury.
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
- Double
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic spinal cord injury less than 100 days.
- •Must be able to swallow tablets and sit upright.
排除标准
- •Bilateral knee flexion contractures.
- •Pregnant, lactating or post-menopausal females.
- •Paget's disease, osteomalacia, steroid induced bone loss, untreated thyroid disease, iritis, uveitis, pancreatitis, gastritis, peptic ulcer or cholecystitis.
- •Treatment in the last year with calcitonin, fluoride or anabolic steroid.
- •Concurrent treatment with prednisone.
结局指标
主要结局
Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.
次要结局
- Change in bone mineral density of the total body, spine and femoral neck between baseline, 12-months and 24-months.
- Change in biochemical markers of bone turnover between baseline, 12-months and 24-months.
- Frequency and severity of adverse events.
- Quality of life.
研究者
研究点 (4)
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