NCT00184678已完成3 期
Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 31
- 主要终点
- Changes in bone mineralisation
研究概览
简要总结
This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child-hood onset growth hormone deficiency
- •Subjects received growth hormone replacement therapy during pre-puberty and puberty
排除标准
- •GH treatment during the month preceding randomisation
- •Treatment within the previous 6 months with medication that may affect bone mineral density
- •Diseases which may affect bone metabolism
结局指标
主要结局
Changes in bone mineralisation
时间窗: After 2 years treatment
次要结局
- Other markers of bone mineral content.
研究者
研究点 (31)
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