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D3-GHR Polymorphism and Turner Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Binder, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00443144
First received: March 2, 2007
Last updated: December 2, 2015
Last verified: December 2015
  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
Short Stature
Drug: recombinant human growth hormone

Study Type: Observational
Official Title: D3-Growth Hormone Receptor Polymorphism and Total Effect of Recombinant Human Growth Hormone on Growth in Girls With Turner Syndrome

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Study Start Date: May 2005
Study Completion Date: May 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   38 Months to 14 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Gerhard Binder, Pediatric Endocrinology, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00443144     History of Changes
Other Study ID Numbers: TS-TUE-FH1 
Study First Received: March 2, 2007
Last Updated: December 2, 2015
Health Authority: Ethics Commission of The Medical Faculty Tubingen, Germany

Keywords provided by University Hospital Tuebingen:
growth hormone receptor polymorphism
pharmacogenomics
growth promoting therapy

Additional relevant MeSH terms:
Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Dwarfism
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016