Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420654
Status:
COMPLETED
Last Update Posted:
2011-11-08
First Post:
2007-01-10
Brief Title:
Growth Hormone Treatment of Women With Turner Syndrome
Sponsor:
Britta E Hjerrild
Organization:
University of Aarhus
Study Overview
Official Title:
Growth Hormone Treatment of Women With Turner Syndrome Body Composition and Heart Function
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None