NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21,249
- 试验地点
- 1
- 主要终点
- Effect of Norditropin® treatment on height gain (change in height) in children
研究概览
简要总结
This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Judged by the physician as per the Norditropin® label
排除标准
- •Judged by the physician as per the Norditropin® label
研究组 & 干预措施
A
Adult cohort
干预措施: somatropin (Drug)
B
Paediatric cohort
干预措施: somatropin (Drug)
结局指标
主要结局
Effect of Norditropin® treatment on height gain (change in height) in children
时间窗: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Effect of Norditropin® treatment on body weight and body composition in adults
时间窗: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
次要结局
- Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children(Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.)
- Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adults(Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.)