NCT00049829已完成3 期
HORIZON-PFT: Pivotal Fracture Trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7,700
- 试验地点
- 119
- 主要终点
- Incidence of hip fxs
研究概览
简要总结
HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.
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
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 65-89 years old
- •No history of severe liver, kidney or eye disease
排除标准
- •Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate)
- •Using hip protectors
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Incidence of hip fxs
Incidence of new vertebral fxs
次要结局
- Percent change in hip BMD
- New and/or worsening vertebral fxs
- All clinical fxs
研究者
研究点 (119)
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