EUCTR2015-003539-37-Outside-EU/EEA进行中(未招募)不适用
An international, multicenter, randomized, open-label, parallel efficacy, and safety trial of intravenous zoledronic acid compared to intravenous pamidronate in children with severe osteogenesis imperfect.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- ovartis
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or Female children between 3 months and 17 years old
- •OI type I, III or IV
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 158
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
研究者
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