ISRCTN95879580已完成2 期
An international, multicentre, open-label, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta
ovartis Pharmaceuticals (Canada)0 个研究点目标入组 20 人开始时间: 2010年1月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Children, male or female, 2 weeks to less than 12 months of age, at least at 38 weeks gestational age
- •2. Any child with phenotypic OI type II, III or IV
- •3. No previous treatment with bisphosphonates
- •4. Negative urine protein as measured by dipstick. One repeat assessment of the urine protein will be allowed. The assessment will be make 2 weeks after the first assessment and the sample must be a urine collection after a 4-hour fast
排除标准
- •1. Blood oxygen saturation of less than 90% in room air
- •2. Serum creatinine level greater than 56 µmol/L
- •3. Any clinically significant clinical laboratory abnormalities at screening
- •4. Treatment with any investigational drug within the past 30 days
- •5. Patients who are unlikely to be able to complete the study or comply with the visit schedule
- •6. Any disease or planned therapy which will interfere with the procedures or data collection of this trial
研究者
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