jRCT2061230103招募中不适用
A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amgen K.K.
- 入组人数
- 106
- 主要终点
- Number of Clinical Fractures
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
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 5age old over 至 17age old under（—）
- 性别
- All
入选标准
- •Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
- •Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- •Ambulatory male and female children and adolescents, age 5 to <18 years, including ambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI) population.
- •Clinical diagnosis of OI, defined as clinical history consistent with type I, III, or IV OI as determined by presence of expected phenotype (examples include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis).
- •If familial, also must be autosomal dominant.
- •Meets at least one of the following:
- •3 or more fractures within the previous 2 years, or
- •1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or
- •2 or more prevalent vertebral fractures.
排除标准
- •Disease Related
- •History of an electrophoresis pattern inconsistent with type I, III or IV OI.
- •History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease.
- •History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation.
结局指标
主要结局
Number of Clinical Fractures
时间窗: 12 months
Clinical fractures include clinical vertebral fractures and nonvertebral fractures.
Number of Any Fractures
时间窗: 12 months
Fractures include new and worsening vertebral compression fractures, whether clinically silent or manifest, and nonvertebral fractures.
次要结局
未报告次要终点
研究者
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