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临床试验/NCT01580605
NCT01580605已完成不适用

Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 331 人开始时间: 2003年7月17日最近更新:
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
331
试验地点
1
主要终点
Weight

研究概览

简要总结

This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients receiving growth hormone therapy, assess efficacy and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.

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

入选标准

  • Adult with growth hormone deficiency
  • Treated with Norditropin® SimpleXx (somatropin)

排除标准

  • 未提供

研究组 & 干预措施

Users of somatropin

干预措施: somatropin (Drug)

结局指标

主要结局

Weight

时间窗: Once a year for 5 years

Waist:Hip Ratio

时间窗: Once a year for 5 years

Body composition

时间窗: Once a year for 5 years

Body mass index (BMI)

时间窗: Once a year for 5 years

次要结局

  • Lipids: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides(Once a year for 5 years)
  • Dose prescribed(Once a year for 5 years)
  • IGF-1 (Insulin-like growth factor 1) concentration(Once a year for 5 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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