Bisphosphonate Treatment of Osteogenesis Imperfecta

Novartis Pharmaceuticals19 个研究点分布在 1 个国家目标入组 158 人开始时间: 2003年6月最近更新: 2017年6月1日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 158
试验地点: 19
主要终点: Change in lumbar spine bone mineral density at month 12 relative to baseline

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.

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: 3 Months 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Change in lumbar spine bone mineral density at month 12 relative to baseline

次要结局

Change in Z score of the lumbar spine at month 12 relative to baseline

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

研究点 (19)

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