NCT00089674已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 1,468
- 主要终点
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
研究概览
简要总结
This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
AMG 162
Experimental
干预措施: AMG 162 (Drug)
结局指标
主要结局
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
时间窗: 24 months
Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.
次要结局
- Total Hip Bone Mineral Density Percent Change From Baseline at Month 24(24 months)
- Number of Participants With a New Vertebral Fracture Through Month 36(36 months)
- Number of Participants With Any Fracture Through Month 36(36 months)
- Total Hip Bone Mineral Density Percent Change From Baseline at Month 36(36 months)
- Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24(24 months)
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36(36 months)
- Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36(36 months)
- Time to First Clinical Fracture Through Month 36(36 months)
- Number of Participants With Any Fracture Through Month 24(24 months)
研究者
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