Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22,960
- 试验地点
- 1
- 主要终点
- Change in height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic.
研究概览
简要总结
This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained
- •Children or adult patients treated with Norditropin® for an appropriate condition as prescribed by their physician
排除标准
- •Patients not being treated with Norditropin®
- •Patients who have discontinued treatment with Norditropin®
- •Known or suspected allergy to Norditropin® or related products
- •Contraindications for somatropin treatment consistent with the Prescribing Information for Norditropin®
研究组 & 干预措施
A
干预措施: somatropin (Drug)
结局指标
主要结局
Change in height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic.
时间窗: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.
Change in waist/hip circumference ratio for adult patients
时间窗: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study
次要结局
- Final Height SDS - Target Height SDS, Final height SDS - predicted adult height SDS(measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.)
- Short-term: Height, Height velocity, Height velocity standard deviation score (SDS), predicted adult height, height SDS for bone age, Proportion achieving height SDS > -2 at end of observational duration period(measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.)
- Final Height (or Adult height), Final Height SDS, near-adult height, near-adult height SDS, Final Height - Target Height, Final height - predicted adult height, height age(measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.)
- Proportion achieving HSDS of more than -2 at final height(measurement made by physician at study entry, annually, or more frequently at physician discretion during the study.)
- Weight, waist circumference, and hip circumference for adult patients(measurement made by physician at study entry, annually, or more frequently at physician discretion during the study)