NCT01522521已完成3 期
Phase 3 Study of AK156 in Primary Osteoporosis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 主要终点
- New vertebral fractures
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with primary osteoporosis
- •Patients who have vertebral fractures at the time of screening
排除标准
- •Patients diagnosed with secondary osteoporosis
- •Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study
研究组 & 干预措施
1.
Experimental
干预措施: AK156 (Drug)
2.
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
New vertebral fractures
时间窗: 2 Years
Reduction in the incidence rate of new fragility vertebral fractures
次要结局
- Clinical fractures(2 Years)
- Vertebral fractures (worsening and new)(2 Years)
- Bone mineral density(2 Years)
- Bone metabolic marker(2 Years)
研究者
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