NCT00238745已完成2 期
Bone Mineral Density Increase and Safety of TSE-424 Compared to Placebo in Osteoporotic Postmenopausal Women
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 375 人开始时间: 2003年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 375
- 主要终点
- Bone mineral density of lumbar spine (L1-L4) at 2 years.
研究概览
简要总结
Dose-response in Japanese patients with postmenopausal osteoporosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be postmenopausal and diagnosed as osteoporosis based on bone mineral density and/or vertebral fracture.
排除标准
- •Diseases which possibly induce secondary osteoporosis or osteopenia and affect on bone metabolism.
结局指标
主要结局
Bone mineral density of lumbar spine (L1-L4) at 2 years.
次要结局
- Bone metabolic makers, bone fracture, bone mineral density of lumbar spine (L2-L4) and lip, lipid parameters, height and adverse events.
研究者
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