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.

Sponsor:

Information provided by:

University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT00443144

First received: March 2, 2007

Last updated: NA

Last verified: March 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

March 2, 2007

Last Updated Date

March 2, 2007

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Turner Syndrome
Growth

Intervention ^ICMJE

Drug: recombinant human growth hormone

Study Group/Cohort (s)

Not Provided

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

38 Months to 14 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00443144

Other Study ID Numbers ^ICMJE

TS-TUE-FH1

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital Tuebingen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gerhard Binder, M.D. PhD

University-Children's Hospital Tübingen

Information Provided By

University Hospital Tuebingen

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top