DRKS00004521已完成2 期
Translational therapy in patients with osteogenesis imperfecta - a pilot trial on treatment with the RANKL-antibody Denosumab - OI-AK
Klinik und Poliklinik für Kinder- und Jugendmedizin0 个研究点目标入组 10 人开始时间: 2013年2月15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
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 5 Years 至 10 Years（—）
- 性别
- All
入选标准
- •Male or female subjects between 5 years and 10 years of age with molecular proven Osteogenesis imperfecta (COL1A1/2 mutation)
- •Subjects must have been treated for a minimum of 2 years with i.v. bisphosphonates prior to study entry
排除标准
- •Hypocalcemia (<1.03 mmol/l ionized Calcium)
- •Subjects with reduced renal function (estimated GFR (Schwartz formula) <30ml/min/1.73m2)
- •Any other abnormal finding such as physical examination or laboratory evaluation, in the opinion of the investigator that is indicative of a disease that would compromise the safety of the patient when getting Denosumab s.c.
研究者
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