NCT00089661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 Aromatase Inhibitor Therapy for Non-metastatic Breast 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
- 252
- 主要终点
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
研究概览
简要总结
The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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
AMG 162 / Denosumab
Experimental
干预措施: AMG 162 / Denosumab (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
时间窗: 12 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
次要结局
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6(6 months)
- Total Hip Bone Mineral Density Percent Change From Baseline at Month 12(12 months)
- Total Hip Bone Mineral Density Percent Change From Baseline at Month 6(6 months)
- Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12(12 months)
- Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6(6 months)
研究者
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