Growth deficit R62.8
Conditions
Interventions
Group 1: Treatment with any approved somatropin product
Sponsors
GWT-TUD GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Concomitant participation in a controlled GH-related clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Overall aim: to assess/analyze somatropin drug utilization (selection of patients, dose and dosing pattern, duration of treatment) within routine clinical practice | — |
Secondary
| Measure | Time frame |
|---|---|
| - to describe the long-term efficacy of somatropin + real final (adult) height (primary endpoint in children), + body composition (primary endpoint in adults) + describe changes in PROs over the initial 2 years of GH treatment, and long term (children and adults). - to collect information on temporarily untreated patients The safety objective is to describe the long-term safety of somatropin (endpoint: type and number of adverse events). Explorative Objective(s) - to assess / analyze additional parameters potentially modulated by GHT e.g., body composition by DXA. - to assess subgroups of the population under observation, or to assess outcomes by participating centers | — |
Countries
Germany
Contacts
Public ContactLinda Kottke
GWT-TUD GmbH
Outcome results
None listed