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NCT00443144 Clinical Trial

D3-GHR Polymorphism and Turner Syndrome

Turner Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00443144
Other study ID # TS-TUE-FH1
Secondary ID
Status Completed
Phase N/A
First received March 2, 2007
Last updated December 2, 2015
Start date May 2005
Est. completion date May 2007

Study information
Verified date December 2015
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Ethics Commission of The Medical Faculty Tubingen, Germany
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date May 2007
Est. primary completion date April 2007
Accepts healthy volunteers
Gender Female
Age group 38 Months to 14 Years
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• recombinant human growth hormone

Locations
Country Name City State
Germany University-Children's Hospital Tübingen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Dos Santos C, Essioux L, Teinturier C, Tauber M, Goffin V, Bougnères 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. — View Citation

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