NCT00097825已完成3 期
Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 51
- 主要终点
- To compare % change in Lumbar Spine BMD from Baseline to Month 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
研究概览
简要总结
The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.
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
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 25-85 years old
排除标准
- •Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate)
- •History of severe liver, kidney or eye disease
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
To compare % change in Lumbar Spine BMD from Baseline to Month 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
次要结局
- To compare % change in Lumbar Spine BMD from Baseline to Months 6 and 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
- To compare % change in BMD at the Total Hip, Femoral Neck, Trochanter and Total Body, from Baseline to Months 6, 12 and 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
- To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline
研究者
研究点 (51)
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