INvestigating SIGnificant Health TrendS in Growth Hormone Treatments Registry

Conditions: Growth deficit
R62.8
Other lack of expected normal physiological development

Registration Number: DRKS00027394

Lead Sponsor: GWT-TUD GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Enrolling by invitation

Sex: All

Target Recruitment: 1500

Inclusion Criteria

Children and adolescents (0-17 years), and adults (18+ years), are eligible for documentation if
they
- are treated with any approved somatropin product
- are treated within the labelling of the respective product
- are available for long term follow-up
- or their parents/guardian have provided informed consent

Exclusion Criteria

Concomitant participation in a controlled GH-related clinical trial

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To provide comprehensive information on different aspects of somatropin treatment in Germany within routine clinical practice: utilization, efficacy, safety, quality of life and other patient related outcomes (PRO), including post-treatment follow-up in various approved indications. <br>Overall aim: to assess/analyze somatropin drug utilization (selection of patients, dose and dosing pattern, duration of treatment) within routine clinical practice

Secondary Outcome Measures

Name	Time	Method
- to describe the long-term efficacy of somatropin<br>+ real final (adult) height (primary endpoint in children),<br>+ body composition (primary endpoint in adults)<br>+ describe changes in PROs over the initial 2 years of GH treatment, and long term (children and adults).<br>- to collect information on temporarily untreated patients <br>The safety objective is to describe the long-term safety of somatropin (endpoint: type and number of adverse events).<br>Explorative Objective(s)<br>- to assess / analyze additional parameters potentially modulated by GHT e.g., body composition by DXA.<br>- to assess subgroups of the population under observation, or to assess outcomes by participating centers<br>