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

NCT00488124 | Completed Phase 2

• 1 other identifier: NRA6280030
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 13

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.

Conditions

Idiopathic Short Stature

Keywords

short stature

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

somatropin (Genotropin® treatment) DRUG

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

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (13)

Kinderklinik, Universitätsklinikum der RWTH Aachen, Pauwelsstraße 30

Aachen, 52074, Germany

Location

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

Cologne, 50931, Germany

Location

Klinik und Poliklinik für Kinder und Jugendliche der Technischen Universität Dresden, Fetscherstr. 74

Dresden, 01307, Germany

Location

Klinik für Kinder und Jugendliche, Schwerpunkt Kinder-Endokrinologie und - Diabetologie, Loschgestr. 15

Erlangen, 91054, Germany

Location

Klinik für Päd. Hämatologie, Onkologie und Endokrinologie, Zentrum für Kinderheilkunde, der Universität Duisburg-Essen, Hufelandstrasse 55

Essen, 45122, Germany

Location

Kinder- und Jugendärztin, Pippinplatz 4

Gauting, 82131, Germany

Location

Endokrinologikum Hamburg, Lornsenstrasse 4 - 6

Hamburg, 22767, Germany

Location

Kinderarztpraxis, Brabeckstrasse 153

Hanover, 30539, Germany

Location

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

Heidelberg, 69120, Germany

Location

Universitätsklinik für Kinder- und Jugendmedizin, Kirrberger Strasse

Homburg/Saar, 66421, Germany

Location

Zentrum für Frauen und Kindermedizin, Liebigstrasse 20 a

Leipzig, 04103, Germany

Location

Klinik für Allgemeine Pädiatrie und Neonatologie, Otto-von-Guericke-Universität Magdeburg, Leipziger Straße 44

Magdeburg, 39112, Germany

Location

Klinik für Kinderheilkunde und Jugendmedizin, Sektion Pädiatrische Endokrinologie, Hoppe-Seyler-Straße 1

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Dwarfism

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Helmuth-Günther Doerr, Prof. Dr.

  Friedrich-Alexander-Universität Erlangen-Nürnberg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 19, 2007
• Study Start: November 1, 2005
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

DE (13)