A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12
研究概览
简要总结
The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.
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
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age
- •Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.
排除标准
- •A BMD T score ≤ -3.50 at the hip,
- •History of hip fracture
- •Severe metabolic bone diseases
- •Significant laboratory abnormalities
- •Recent treatment with agents affecting bone metabolism
研究组 & 干预措施
Romosozumab
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
干预措施: Romosozumab (Biological)
Placebo
Participants received placebo subcutaneous injections once a month for 12 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12
时间窗: Baseline and month 12
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
次要结局
- Percent Change From Baseline in BMD at the Femoral Neck at Month 6(Baseline and month 6)
- Percent Change From Baseline in BMD at the Femoral Neck at Month 12(Baseline and month 12)
- Percent Change From Baseline in Lumbar Spine BMD at Month 6(Baseline and month 6)
- Percent Change From Baseline in BMD at the Total Hip at Month 6(Baseline and month 6)
- Percent Change From Baseline in BMD at the Total Hip at Month 12(Baseline and month 12)