NCT02720770已完成1 期
Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial
Bicetre Hospital0 个研究点目标入组 19 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 主要终点
- change from baseline in height SDS (standard deviation score)
研究概览
简要总结
This study evaluates the effect on height of a two year treatment with growth hormone in 19 children with X linked hypophosphatemic rickets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical, biochemical and genetic diagnosis of XLH
- •height SDS < 2
- •at least two years of treatment with oral phosphate and calcitriol
排除标准
- •uncontrolled rickets (ALP>600 IU)
- •growth hormone deficiency
- •hyperparathyroidism, nephrocalcinosis, renal insufficiency
- •associated disease
- •previous treatment with growth hormone
研究组 & 干预措施
norditropine simplex
Experimental
干预措施: norditropine simplex (Drug)
结局指标
主要结局
change from baseline in height SDS (standard deviation score)
时间窗: at year one and year two from baseline
次要结局
未报告次要终点
研究者
Alessia Usardi
Professor
Bicetre Hospital
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