NCT00091793已完成3 期
A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
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
- 332
- 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 determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 90 Years（Child, 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
Experimental
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
干预措施: AMG 162 (Drug)
Placebo
Placebo Comparator
Placebo given day 1, month 6, month 12 and month 18
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 24
时间窗: 24 Months
Bone Mineral Density 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)
- Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24(24 months)
- Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24(24 months)
- Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24(24 Months)
- Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24(24 months)
- Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24(24 months)
- Trochanter Bone Mineral Density Percent Change From Baseline at Month 24(24 months)
- Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24(24 months)
研究者
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