A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 34
- 主要终点
- Percent Change From Baseline in Lumbar Spine BMD at Month 12
研究概览
简要总结
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
详细描述
The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide 80 micrograms (mcg) per day administered subcutaneously (SC) compared to placebo in men with osteoporosis. Efficacy was primarily assessed by the change in bone mineral density (BMD) over 12 months.
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)
盲法说明
Treatment will be blinded to participants, investigators, outcome Assessor and care provider throughout the study except in a medical emergency where the identity of study medication is necessary to appropriately treat the participant.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Abaloparatide
Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.
干预措施: Abaloparatide (Drug)
Placebo
Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Lumbar Spine BMD at Month 12
时间窗: Baseline, Month 12
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
次要结局
- Percent Change From Baseline in Total Hip BMD at Month 12(Baseline, Month 12)
- Percent Change From Baseline in Femoral Neck BMD at Month 12(Baseline, Month 12)
- Percent Change in Total Hip BMD From Baseline at Month 6(Baseline, Month 6)
- Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12(Baseline, Month 12)
- Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12(Baseline, Month 12)
- Number of Participants With New Clinical Fractures(Baseline through Month 12)
- Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12(Baseline, Month 12)
- Percent of Participants With Change in Disease Status(Baseline through Month 12)
- Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip(Month 12)
- Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12(Baseline, Month 12)
- Percent Change From Baseline in Lumbar Spine BMD at Month 6(Baseline, Month 6)
- Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12(Baseline, Month 12)
- Percent Change From Baseline in Femoral Neck BMD at Month 6(Baseline, Month 6)
- Percent Change From Baseline in Distal One-third Radius BMD at Month 12(Baseline, Month 12)