NCT00212667已完成3 期
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 650
- 主要终点
- New fragility vertebral fracture
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.
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
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis
- •Patients having radiographically confirmed vertebral (T4-L4) fractures
- •Other inclusion criteria as specified in the study protocol
排除标准
- •Patients having secondary osteoporosis or another condition that presents low bone mass
- •Patients having findings on X-ray that affect evaluation of vertebral fracture
- •Patients that have been administered bisphosphonate derivatives
- •Other exclusion criteria as specified in the study protocol
结局指标
主要结局
New fragility vertebral fracture
次要结局
- New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain
研究者
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