A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
研究概览
简要总结
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
详细描述
Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:
- Romosozumab 90 mg/mL
- Placebo 90 mg/mL
- Romosozumab 70 mg/mL
- Placebo 70 mg/mL
After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.
For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with osteoporosis at high risk for fracture defined as
- •BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
- •a history of fragility fracture or at least 2 other risk factors
排除标准
- •BMD T score < -3.50 at the total hip or femoral neck.
- •History of hip fracture.
- •History of metabolic or bone disease (except osteoporosis).
- •Use of agents affecting bone metabolism.
- •Vitamin D insufficiency.
- •History of solid organ or bone marrow transplants.
- •Hyper- or hypocalcemia.
- •Hyper- or hypothyroidism.
- •Hyper- or hypoparathyroidism.
研究组 & 干预措施
Romosozumab 90 mg/mL
Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months.
干预措施: Romosozumab 90 mg/mL (Drug)
Placebo 90 mg/mL
Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.
干预措施: Placebo 90 mg/mL (Drug)
Romosozumab 70 mg/mL
Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months.
干预措施: Romosozumab 70 mg/mL (Drug)
Placebo 70 mg/mL
Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.
干预措施: Placebo 70 mg/mL (Drug)
结局指标
主要结局
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine
时间窗: Baseline and month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
次要结局
- Percent Change From Baseline in Femoral Neck BMD(Baseline and month 6)
- Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)(Baseline, month 1, month 3, and month 6)
- Percent Change From Baseline in Total Hip BMD(Baseline and month 6)
- Percent Change From Baseline in Serum C-Telopeptide (CTX)(Baseline, month 1, month 3, and month 6)