NCT00100607已完成2 期
Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 676
- 主要终点
- Lumbar spine BMD and total hip BMD after 1 year treatment
研究概览
简要总结
This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with 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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMD T Score between -2 to -3.5
- •50-75 years old
排除标准
- •Urolithiasis
- •Bisphosphonates
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Lumbar spine BMD and total hip BMD after 1 year treatment
Safety and tolerability of one year treatment with different doses
次要结局
- Effect of the different doses on BMD of lumbar spine, femoral neck, total hip, forearm and total body
- Effect of the different doses on markers for bone formation and bone resorption
- Structural information on cortical and trabecular bone at different anatomic sites after 6 and 12 months of treatment
- Histological information on bone biopsy after 12 months of treatment
研究者
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