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临床试验/NCT00046254
NCT00046254已完成3 期

Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture

Novartis Pharmaceuticals56 个研究点 分布在 2 个国家目标入组 2,127 人开始时间: 2002年2月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
2,127
试验地点
56
主要终点
Significant reduction in rate of clinical fractures after surgical repair of hip fracture

研究概览

简要总结

The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive vitamin D and calcium.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female ages 50 years or older
  • Must have a recent hip fracture repair in the past 90 days
  • Must be able to walk with or without assistive device (for example, using a walker) prior to the hip fracture

排除标准

  • Current bisphosphonate users such as aredia (pamidronate), didronel (etidronate), fosamax (alendronate), actonel (residronate), skelid (tiludronate)
  • Other protocol-defined inclusion/exclusion criteria may apply.

结局指标

主要结局

Significant reduction in rate of clinical fractures after surgical repair of hip fracture

次要结局

  • Increase in total hip and femoral neck BMDs

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (56)

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