NCT00934063已完成不适用
A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 主要终点
- Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density
研究概览
简要总结
This observational study is conducted in Europe. The aim of this observational study is to investigate the changes in a score (GET-score) which includes quality of life, body composition and cholesterol metabolism in patients on growth hormone treatment. The GET score stands for: Growth hormone deficiency and Efficacy of Treatment, and is a quantitative measurement of the efficacy of the treatment with growth hormone in adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe acquired growth hormone deficiency
- •No treatment with somatropin in the last 24 months before study participation
- •Written informed consent
排除标准
- •Contraindications for the treatment with somatropin
研究组 & 干预措施
A
干预措施: somatropin (Drug)
B
干预措施: No treatment given (Other)
结局指标
主要结局
Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density
时间窗: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
次要结局
- Health related quality of life (SF-36; EQ-5D)(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
- Disease related absences from work(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
- Bone mineral density DXA Z-score lumbar(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
- Total cholesterol, HDL, LDL(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
- Body composition: fat mass, fat-free mass, impedance (BIA)(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
- Waist-circumference(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
- Blood pressure(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
- Adverse Drug Reactions and Severe Adverse Drug Reactions(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
- Triceps skinfold thickness(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
- Upper arm circumference(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
- IGF-I (Insulin-like growth factor 1)(at 0, 3, 6, 12, 18 and 24 months after treatment initiation)
研究者
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