A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
研究概览
简要总结
The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal 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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)
排除标准
- •Severe osteoporosis
- •Use of agents affecting bone metabolism
- •History of metabolic or bone disease (except osteoporosis)
- •Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
- •Current hyper- or hypocalcemia
- •Current, uncontrolled hyper- or hypothyroidism
- •Current, uncontrolled hyper- or hypoparathyroidism
研究组 & 干预措施
Placebo
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
干预措施: Placebo (Drug)
Romosozumab 70 mg
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
干预措施: Romosozumab (Drug)
Romosozumab 140 mg
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
干预措施: Romosozumab (Drug)
Romosozumab 210 mg
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
干预措施: Romosozumab (Drug)
结局指标
主要结局
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
时间窗: Baseline and 12 months
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.
次要结局
- Percent Change From Baseline in Osteocalcin(Baseline, week 1, and months 1, 2, 3, 6, 9, and 12)
- Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)(Baseline, week 1, and months 1, 2, 3, 6, 9, and 12)
- Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine(Baseline and 6 months)
- Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip(Baseline and 6 months)
- Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck(Baseline and 6 months)
- Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck(Baseline and 12 months)
- Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)(Baseline, week 1, and months 1, 2, 3, 6, 9, and 12)
- Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)(Baseline, week 1, and months 1, 2, 3, 6, 9, and 12)
- Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip(Baseline and 12 months)
- Area Under the Curve Through Month 12 of P1NP(Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.)