NCT00532337已完成2 期
A Multi-centre, Randomized, Double Blind, Parallel Group Study to Investigate Efficacy and Safety of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Mean bone mineral density of the lumbar spine (L 1-4 BMD)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean (T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR
- •Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean, but less than 2.5 SD below this value (T-score <-1 and >2.5) at the lumbar spine (L1 to L4) or total hip.
排除标准
- •Patients with a value of DXA BMD more that 3.5 SD below the young adult mean, (T-score <-3.5) at the lumbar spine (L1 to L4) or total hip.
- •Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive.
- •Osteopenia patients (T-score <-1 and >-2.5) who have no vertebral fragility fractures between T4 and L4 inclusive, OR
- •Osteopenia patients (T-score <-1 and >-2.5) who have two or more vertebral fragility fractures between T4 and L4 inclusive.
- •Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD.
- •Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism.
- •Other exclusion criteria as specified in the study protocol.
研究组 & 干预措施
P
Placebo Comparator
干预措施: ONO-5334 (Drug)
E1
Experimental
干预措施: ONO-5334 (Drug)
E2
Experimental
干预措施: ONO-5334 (Drug)
E3
Experimental
干预措施: ONO-5334 (Drug)
A
Active Comparator
干预措施: ONO-5334 (Drug)
结局指标
主要结局
Mean bone mineral density of the lumbar spine (L 1-4 BMD)
时间窗: 12 months
次要结局
- Bone mineral density at hip, Biochemical markers of bone turnover(during course of treatment of 12 months)
研究者
研究点 (1)
Loading locations...
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