NCT00306189已完成2 期
Dose Response Study of AMG 162 (Denosumab) in Subjects With Osteoporosis - A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects -
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 212
- 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 primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.
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 (Participant, Investigator)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip.
排除标准
- •Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.
研究组 & 干预措施
100 mg AMG 162
Active Comparator
干预措施: 100 mg AMG 162 (Drug)
60 mg AMG 162
Active Comparator
干预措施: 60 mg AMG 162 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
14 mg AMG 162
Active Comparator
干预措施: 14 mg AMG 162 (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
未报告次要终点
研究者
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