NCT00138866已完成3 期
Risedronate for Treatment of Sublesional 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
- 46
- 试验地点
- 2
- 主要终点
- Change in bone mineral density of the distal femur between baseline and 18-months
研究概览
简要总结
The purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with 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
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic spinal cord injury of greater than 18 months
- •Osteopenia or osteoporosis of the hip
- •Must be able to swallow tablets and sit upright
排除标准
- •Bilateral heterotopic ossification
- •Bilateral lower extremity metal implants
- •Pregnant or lactating females
- •Paget's disease
- •Osteomalacia
- •Steroid induced bone loss
- •Untreated parathyroid or thyroid disease
- •Symptomatic hypocalcemia or hypophosphatemia
- •Treatment in the last year with calcitonin, fluoride or anabolic steroids
- •Current treatment with prednisone
结局指标
主要结局
Change in bone mineral density of the distal femur between baseline and 18-months
时间窗: 18 months
次要结局
- Change in bone mineral density of the hips and proximal tibia between baseline and 18-months(18 months)
- The change in biochemical bone markers of bone turnover between baseline and 18-months(18 months)
- The frequency and severity of adverse events(18 months)
研究者
研究点 (2)
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