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

NCT ID: NCT00488124

Last Updated: 2020-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2011-03-31

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.

Conditions

Idiopathic Short Stature

Keywords

short stature

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

somatropin (Genotropin® treatment)

0,035 mg /kg bodyweight of Somatropin per day given by subcutaneous injections through an injection device (GenotropinPEN)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Childrens´ hospital

Principal Investigators

Helmuth-Günther Doerr, Prof. Dr.

Role: STUDY_CHAIR

Friedrich-Alexander-Universität Erlangen-Nürnberg

Locations

Kinderklinik, Universitätsklinikum der RWTH Aachen, Pauwelsstraße 30

Aachen, , Germany

Klinik u. Poliklinik für Kinder und Jugendliche, Med. Einrichtungen der Universität Köln, Joseph-Stelzmann-Strasse 9

Cologne, , 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

Hanover, , Germany

Universitätsklinik für Kinder- und Jugendliche, Abt. Kinderheilkunde, Im Neuenheimer Feld 430

Heidelberg, , Germany

Universitätsklinik für Kinder- und Jugendmedizin, Kirrberger Strasse

Homburg/Saar, , 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, , Germany

Countries

Germany

Other Identifiers

NRA6280030

Identifier Type: -

Identifier Source: org_study_id