Back to resultsD3-GHR Polymorphism and Turner Syndrome
Primary Purpose
Turner Syndrome, Short Stature
Status
Completed
Phase
Locations
Germany
Study Type
Observational
Intervention
recombinant human growth hormone
Sponsored by
About this trial
This is an observational trial for Turner Syndrome focused on measuring growth hormone receptor polymorphism, pharmacogenomics, growth promoting therapy
Eligibility 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.
Sites / Locations
- University-Children's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00443144
First Posted
March 2, 2007
Last Updated
December 2, 2015
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT00443144
Brief Title
D3-GHR Polymorphism and Turner Syndrome
Official Title
D3-Growth Hormone Receptor Polymorphism and Total Effect of Recombinant Human Growth Hormone on Growth in Girls With Turner Syndrome
Study Type
Observational
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Turner Syndrome, Short Stature
Keywords
growth hormone receptor polymorphism, pharmacogenomics, growth promoting therapy
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
recombinant human growth hormone
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
38 Months
Maximum Age & Unit of Time
14 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Binder, M.D. PhD
Organizational Affiliation
University-Children's Hospital Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University-Children's Hospital
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
15208626
Citation
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. doi: 10.1038/ng1379. Epub 2004 Jun 20.
Results Reference
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D3-GHR Polymorphism and Turner Syndrome
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