NCT02791516已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Postmenopausal South Korean Women With 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
- 67
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine
研究概览
简要总结
The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.
- •Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening.
- •BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck.
- •At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA.
- •Other inclusion criteria may apply.
排除标准
- •Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck.
- •History of hip fracture.
- •Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities.
- •Known sensitivity or intolerance calcium and vitamin D products.
- •Other exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received placebo subcutaneous injection once a month for 6 months.
干预措施: Placebo (Drug)
Romosozumab
Experimental
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
干预措施: Romosozumab (Drug)
结局指标
主要结局
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine
时间窗: Baseline and month 6
Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
次要结局
- Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip(Baseline and month 6)
- Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck(Baseline and month 6)
研究者
研究点 (1)
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