NCT00131118已完成2 期
Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 18
- 主要终点
- Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202
研究概览
简要总结
This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.
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
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed the core CZOL446H2202 study
- •Males or females between 1-17 years of age
排除标准
- •Deformity or abnormality which would prevent spine bone density from being done
- •Any surgical bone-lengthening procedure
- •Any kidney diseases or abnormalities
- •Low calcium or vitamin D levels in the blood
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202
次要结局
- Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
研究者
研究点 (18)
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