D3-GHR Polymorphism and Turner Syndrome

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT00443144

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Turner Syndrome Short Stature	Drug: recombinant human growth hormone

Study Design

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

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

38 Months to 14 Years

Sexes Eligible for Study:

Female

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.