D3-GHR Polymorphism and Turner Syndrome | NCT00443144

Studies
D3-GHR Polymorphism and Turner Syndrome

NCT00443144

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Dec 3, 2015Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Turner Syndrome
Short Stature

Interventions

recombinant human growth hormone

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Apr 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Mar 2, 2007

First Submission Date that Met QC Criteria

Mar 2, 2007

First Posted Date

Mar 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gerhard Binder, Pediatric Endocrinology, University Hospital TuebingenPrincipal Investigator

Lead Sponsor

University Hospital TuebingenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
recombinant human growth hormone	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

38 Months

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerhard Binder, M.D. PhD	University-Children's Hospital Tübingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University-Children's Hospital		Tübingen		72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15208626	Background	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.

ID	Term
D014424	Turner Syndrome
D004392	Dwarfism

ID	Term
D006059	Gonadal Dysgenesis
D012734	Disorders of Sex Development
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases

ID	Term
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones