D3-Growth Hormone Receptor Polymorphism and Total Effect of Recombinant Human Growth Hormone on Growth in Girls With Turner Syndrome

This study has been completed.

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00443144

Purpose

The protein polymorphism of the growth hormone receptor characterized by the genomic deletion of exon 3 has been linked to the magnitude of the first-year-growth response to growth hormone (GH) in girls with Turner syndrome.

Objective: to study the long-term effect of GH therapy in Turner syndrome in correlation to this GHR polymorphism in a mainly retrospective design (chart-review).

Condition	Intervention
Turner Syndrome Growth	Drug: recombinant human growth hormone

Genetics Home Reference related topics: Turner syndrome

MedlinePlus related topics: Turner Syndrome

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Longitudinal, Defined Population, Retrospective/Prospective Study

Eligibility

Ages Eligible for Study:	38 Months to 14 Years
Genders Eligible for Study:	Female

Criteria

Inclusion Criteria:

Turner syndrome defined by a structural aberration or lack of the X chromosome.
Growth velocity less than 2 cm/year at the time of final analysis (= final height).

Exclusion Criteria:

Age <3.5 or >14 years at start of GH therapy,
GH peak serum levels < 8 ng/ml in two independent tests,
Thelarche at start or during the first year of treatment,
Oxandrolone therapy for any time and a duration of GH therapy less than 2 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443144

Locations

Germany
University-Children's Hospital
Tübingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Gerhard Binder, M.D. PhD

University-Children's Hospital Tübingen

More Information

Publications:

Dos Santos C, Essioux L, Teinturier C, Tauber M, Goffin V, Bougneres P. A common polymorphism of the growth hormone receptor is associated with increased responsiveness to growth hormone. Nat Genet. 2004 Jul;36(7):720-4. Epub 2004 Jun 20.

Study ID Numbers:	TS-TUE-FH1
Study First Received:	March 2, 2007
Last Updated:	March 2, 2007
ClinicalTrials.gov Identifier:	NCT00443144
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:

growth hormone receptor polymorphism
pharmacogenomics
growth promoting therapy

Study placed in the following topic categories:

Chromosomal abnormalities
Genital dwarfism
Gonadal Disorders
Chromosome Disorders
Endocrine System Diseases
Sex Differentiation Disorders
Monosomy X
Turner Syndrome

Gonadal dysgenesis
Urogenital Abnormalities
Genetic Diseases, Inborn
Turner syndrome
Ovarian dwarfism
Endocrinopathy
Congenital Abnormalities
Gonadal Dysgenesis

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Sex Chromosome Disorders

ClinicalTrials.gov processed this record on January 16, 2009