Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin

Idiopathic Short Stature Clinical Trial

— ISS  

Official title:

Evaluation of Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin: A Prospective, Longitudinal Non-randomised, Open, Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488124
• Other study ID #: NRA6280030
• Status: Completed
• Phase: Phase 2
• Start date: November 2005
• Est. completion date: March 2011

Study information

• Verified date: December 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dwarfism
• Idiopathic Short Stature

Intervention

Drug:
• somatropin (Genotropin® treatment)
0,035 mg /kg bodyweight of Somatropin per day given by subcutaneous injections through an injection device (GenotropinPEN)

Locations

Country	Name	City	State
Germany	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	Kinderarztpraxis, Brabeckstrasse 153	Hannover
Germany	Universitätsklinik für Kinder- und Jugendliche, Abt. Kinderheilkunde, Im Neuenheimer Feld 430	Heidelberg
Germany	Universitätsklinik für Kinder- und Jugendmedizin, Kirrberger Strasse	Homburg/Saar
Germany	Klinik u. Poliklinik für Kinder und Jugendliche, Med. Einrichtungen der Universität Köln, Joseph-Stelzmann-Strasse 9	Köln
Germany	Zentrum für Frauen und Kindermedizin, Liebigstrasse 20 a	Leipzig
Germany	Klinik für Allgemeine Pädiatrie und Neonatologie, Otto-von-Guericke-Universität Magdeburg, Leipziger Straße 44	Magdeburg
Germany	Klinik für Kinderheilkunde und Jugendmedizin, Sektion Pädiatrische Endokrinologie, Hoppe-Seyler-Straße 1	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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