A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 7,808
- 主要终点
- Number of Participants With New Vertebral Fractures
研究概览
简要总结
This study will evaluate the effectiveness and safety of denosumab in treating 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are 60 to 90 years of age may be eligible to participate
- •Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5
排除标准
- •BMD T-Score at the hip or the spine of less than -4.0
- •Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry
研究组 & 干预措施
Placebo
Placebo administered subcutaneously once every 6 months for 3 years.
干预措施: placebo (Drug)
Denosumab 60 mg Q6M
Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
干预措施: Denosumab (Drug)
结局指标
主要结局
Number of Participants With New Vertebral Fractures
时间窗: 36 months
A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms \[or both\] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture).
次要结局
- Number of Participants With a Hip Fracture(36 months)
- Number of Participants With Nonvertebral Fractures(36 months)