Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

This study is ongoing, but not recruiting participants.

First Received: September 9, 2005 Last Updated: November 19, 2009 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174187

Purpose

To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
To assess the effect of a long term treatment with Genotonorm on bone mineralisation
To assess the effect of a long term treatment with Genotonorm on body composition

Condition	Intervention	Phase
Endocrine System Diseases	Drug: Somatropin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety.

Resource links provided by NLM:

MedlinePlus related topics: Endocrine Diseases

Drug Information available for: Somatropin Somatotropin

Further study details as provided by Pfizer:

Primary Outcome Measures:

Growth velocity; Number of cm/year [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IGF-1: Insulinlike growth factor-1 [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]
Evolution of bone metabolism by absorptiometry: Radiological test [ Time Frame: Every 12 months ] [ Designated as safety issue: No ]
Evolution of body composition by DEXA: Dual X-ray absorptiometry [ Time Frame: Every 12 months ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	September 2000
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Somatropin: Experimental	Drug: Somatropin liquide, daily, until final height Dosage: 0,46 mg/kg/week

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174187

Locations

France
Pfizer Investigational Site
Paris, France, 75019
Pfizer Investigational Site
Paris, France, 75743

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	307-MET-9002-0009, A6281016
Study First Received:	September 9, 2005
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00174187 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Endocrine System Diseases

ClinicalTrials.gov processed this record on November 30, 2009