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

Primary Purpose

Idiopathic Short Stature

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
somatropin (Genotropin® treatment)
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Short Stature focused on measuring short stature

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kinderklinik, Universitätsklinikum der RWTH Aachen, Pauwelsstraße 30
  • Klinik und Poliklinik für Kinder und Jugendliche der Technischen Universität Dresden, Fetscherstr. 74
  • Klinik für Kinder und Jugendliche, Schwerpunkt Kinder-Endokrinologie und - Diabetologie, Loschgestr. 15
  • Klinik für Päd. Hämatologie, Onkologie und Endokrinologie, Zentrum für Kinderheilkunde, der Universität Duisburg-Essen, Hufelandstrasse 55
  • Kinder- und Jugendärztin, Pippinplatz 4
  • Endokrinologikum Hamburg, Lornsenstrasse 4 - 6
  • Kinderarztpraxis, Brabeckstrasse 153
  • Universitätsklinik für Kinder- und Jugendliche, Abt. Kinderheilkunde, Im Neuenheimer Feld 430
  • Universitätsklinik für Kinder- und Jugendmedizin, Kirrberger Strasse
  • Klinik u. Poliklinik für Kinder und Jugendliche, Med. Einrichtungen der Universität Köln, Joseph-Stelzmann-Strasse 9
  • Zentrum für Frauen und Kindermedizin, Liebigstrasse 20 a
  • Klinik für Allgemeine Pädiatrie und Neonatologie, Otto-von-Guericke-Universität Magdeburg, Leipziger Straße 44
  • Klinik für Kinderheilkunde und Jugendmedizin, Sektion Pädiatrische Endokrinologie, Hoppe-Seyler-Straße 1

Outcomes

Primary Outcome Measures

To show an improvement of height, change in height (SDS) under GH treatment one year after visit 2 (start of GH therapy).

Secondary Outcome Measures

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)

Full Information

First Posted
June 18, 2007
Last Updated
December 10, 2020
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00488124
Brief Title
Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Short Stature
Keywords
short stature

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
somatropin (Genotropin® treatment)
Intervention Description
0,035 mg /kg bodyweight of Somatropin per day given by subcutaneous injections through an injection device (GenotropinPEN)
Primary Outcome Measure Information:
Title
To show an improvement of height, change in height (SDS) under GH treatment one year after visit 2 (start of GH therapy).
Time Frame
one and two years of observation
Secondary Outcome Measure Information:
Title
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)
Time Frame
one and two years of observation period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmuth-Günther Doerr, Prof. Dr.
Organizational Affiliation
Friedrich-Alexander-Universität Erlangen-Nürnberg
Official's Role
Study Chair
Facility Information:
Facility Name
Kinderklinik, Universitätsklinikum der RWTH Aachen, Pauwelsstraße 30
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinik und Poliklinik für Kinder und Jugendliche der Technischen Universität Dresden, Fetscherstr. 74
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Klinik für Kinder und Jugendliche, Schwerpunkt Kinder-Endokrinologie und - Diabetologie, Loschgestr. 15
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinik für Päd. Hämatologie, Onkologie und Endokrinologie, Zentrum für Kinderheilkunde, der Universität Duisburg-Essen, Hufelandstrasse 55
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Kinder- und Jugendärztin, Pippinplatz 4
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Endokrinologikum Hamburg, Lornsenstrasse 4 - 6
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
Facility Name
Kinderarztpraxis, Brabeckstrasse 153
City
Hannover
ZIP/Postal Code
30539
Country
Germany
Facility Name
Universitätsklinik für Kinder- und Jugendliche, Abt. Kinderheilkunde, Im Neuenheimer Feld 430
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinik für Kinder- und Jugendmedizin, Kirrberger Strasse
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinik u. Poliklinik für Kinder und Jugendliche, Med. Einrichtungen der Universität Köln, Joseph-Stelzmann-Strasse 9
City
Köln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Zentrum für Frauen und Kindermedizin, Liebigstrasse 20 a
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinik für Allgemeine Pädiatrie und Neonatologie, Otto-von-Guericke-Universität Magdeburg, Leipziger Straße 44
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
Klinik für Kinderheilkunde und Jugendmedizin, Sektion Pädiatrische Endokrinologie, Hoppe-Seyler-Straße 1
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

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

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