NCT02157948已完成3 期
A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal 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
- 394
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Lumbar Spine BMD
研究概览
简要总结
This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine 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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent prior to any study-specific activities/procedures
- •Ambulatory postmenopausal women.
- •Age 55 years or older
- •Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.
排除标准
- •Administration of osteoporosis treatments or bone active treatments within specific timeframes
- •Vitamin D deficiency
- •Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)
- •Contraindications to denosumab therapy (e.g., hypocalcemia)
研究组 & 干预措施
Denosumab CP4
Experimental
Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
干预措施: Denosumab (CP4) (Drug)
Denosumab CP2
Active Comparator
Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.
干预措施: Denosumab (CP2) (Drug)
结局指标
主要结局
Percent Change From Baseline in Lumbar Spine BMD
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 Serum Type I Collagen C-telopeptide (sCTX)(Baseline, month 1, month 6 and month 12)
- Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)(Baseline, month 1, month 6 and month 12)
研究者
研究点 (1)
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