Growth Hormone Treatment of Women With Turner Syndrome | NCT00420654

Studies
Growth Hormone Treatment of Women With Turner Syndrome

NCT00420654

Sponsor

Britta E. Hjerrild

Status

Completed

Last Update Posted

Nov 8, 2011Estimated

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Turner Syndrome

Interventions

Growth Hormone
Placebo
Healthy controls

Countries

Denmark

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

Nov 2011

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

Aug 2007

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jan 10, 2007

First Submission Date that Met QC Criteria

Jan 10, 2007

First Posted Date

Jan 11, 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

Nov 6, 2011

Last Update Posted Date

Nov 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Growth hormone treatment is used in girls with Turner syndrome to increase final height. The aim of this study is to evaluate the effect of growth hormone treatment on body composition and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass will decrease and lean body mass will increase. There is only very limited documentation of the effect on the heart in this study population.

Detailed Description

This study is a randomised, double-blinded, controlled clinical trial to evaluate the effect of growth hormone (GH) treatment on adult women with Turner syndrome. The endpoints will be changes in body composition and heart function evaluated by echocardiography (ECHO) and positron emission tomography (PET).

Phase one: 6 months of GH or placebo treatment. Phase two: "open label" all participants are treated with GH for 12 months. At baseline, healthy controls will be examined, but will not receive any treatment

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
A1	Active Comparator	Drug: Growth Hormone
A2	Placebo Comparator	Drug: Placebo
A3	Other	Other: Healthy controls

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Growth Hormone	Drug	1.25 mg, 6 months	A1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body composition: fat mass and lean body mass		6 months + 18 months
Myocardial perfusion and glucose uptake, evaluated by positron emission tomography		6 months

Secondary Outcomes

Measure	Description	Time Frame
Heart function evaluated by echocardiography (conventional and tissue doppler)		6 months + 18 months
Lipid profile		6 months + 18 months
24 hour ambulatory blood pressure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Turner syndrome
Age 20-40

Exclusion Criteria:

Symptomatic heart disease
Anti hypertensive treatment
Untreated thyroid disease
Adipositas (BMI > 35)
Treatment with glucocorticoids
Pregnancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens S. Christiansen, prof. dr.med	University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital		Aarhus	DK	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D014424	Turner Syndrome

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013006	Growth Hormone

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided