Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin
- Conditions
- Idiopathic Short Stature
- Registration Number
- NCT00488124
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
Growth hormone therapy will improve the height of short statured children with pathological conditions that lead to growth retardation. Growth hormone therapy will show an increase in height velocity \>1 SD compared to pretreatment height velocity. and the therapy will be safe.
- Detailed Description
Growth hormone (GH, Somatropin, e.g. Genotropin®) is approved in the treatment of children in specific indications. However, besides the benefit in approved indications, a benefit can also be achieved in other pathological conditions that lead to growth retardation. However, because of their relative low frequency and the long duration of GH studies in children, few data or only case reports on GH treatment are available in these conditions. Nevertheless, published data have suggested a benefit of GH treatment in children suffering from some of those diseases and pediatric endocrinologists sometimes request GH treatment for those children to improve growth rate. This protocol is designed to allow such children with severe growth retardation to be treated with GH and will allow those children to be carefully followed-up and finally evaluated at the end of the GH treatment period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Severe growth retardation (< -2,5 height SDS and annual growth velocity (HV SDS) < 0 SD according to Reinken (1992) and parental adjusted target height < -1 SD according to Tanner (1986)
- Chronological age > 4 and < 10 years, prepubertal children; for girls: Tanner breast stage B = 1, for boys: testis volume ≤ 3 ml
- Any disease which is NOT part of the registered indications for GH treatment in Germany
- Written informed consent from both parents and from the patients if she/he is able to receive and understand the information
- GH treatment requested by an expert in pediatric endocrinology
- Participation in any other clinical study
- Unable to follow the and/or comprehend the protocol ( e.g. severe mental retardation)
- Previous history of intolerance or hypersensitivity to the study drug
- History of malignancy
- Chromosomal anomalies with increased risk for malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To show an improvement of height, change in height (SDS) under GH treatment one year after visit 2 (start of GH therapy). one and two years of observation
- Secondary Outcome Measures
Name Time Method To show an increase in height velocity >1 SD compared to pretreatment height velocity, to confirm good clinical and biological safety of GH treatment in these patients (e.g. adverse events, serum IGF-I, fasting blood glucose and insulin) one and two years of observation period
Trial Locations
- Locations (13)
Kinderklinik, Universitätsklinikum der RWTH Aachen, Pauwelsstraße 30
🇩🇪Aachen, Germany
Klinik und Poliklinik für Kinder und Jugendliche der Technischen Universität Dresden, Fetscherstr. 74
🇩🇪Dresden, Germany
Klinik für Kinder und Jugendliche, Schwerpunkt Kinder-Endokrinologie und - Diabetologie, Loschgestr. 15
🇩🇪Erlangen, Germany
Klinik für Päd. Hämatologie, Onkologie und Endokrinologie, Zentrum für Kinderheilkunde, der Universität Duisburg-Essen, Hufelandstrasse 55
🇩🇪Essen, Germany
Kinder- und Jugendärztin, Pippinplatz 4
🇩🇪Gauting, Germany
Endokrinologikum Hamburg, Lornsenstrasse 4 - 6
🇩🇪Hamburg, Germany
Universitätsklinik für Kinder- und Jugendliche, Abt. Kinderheilkunde, Im Neuenheimer Feld 430
🇩🇪Heidelberg, Germany
Klinik u. Poliklinik für Kinder und Jugendliche, Med. Einrichtungen der Universität Köln, Joseph-Stelzmann-Strasse 9
🇩🇪Köln, Germany
Universitätsklinik für Kinder- und Jugendmedizin, Kirrberger Strasse
🇩🇪Homburg/Saar, Germany
Klinik für Allgemeine Pädiatrie und Neonatologie, Otto-von-Guericke-Universität Magdeburg, Leipziger Straße 44
🇩🇪Magdeburg, Germany
Zentrum für Frauen und Kindermedizin, Liebigstrasse 20 a
🇩🇪Leipzig, Germany
Kinderarztpraxis, Brabeckstrasse 153
🇩🇪Hannover, Germany
Klinik für Kinderheilkunde und Jugendmedizin, Sektion Pädiatrische Endokrinologie, Hoppe-Seyler-Straße 1
🇩🇪Tübingen, Germany