Growth Hormone Treatment of Women With Turner Syndrome
Primary Purpose
Turner Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Growth Hormone
Placebo
Healthy controls
Sponsored by
About this trial
This is an interventional treatment trial for Turner Syndrome focused on measuring Turner syndrome, growth hormone treatment, positron emission tomography, heart
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
Sites / Locations
- Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Other
Arm Label
A1
A2
A3
Arm Description
Outcomes
Primary Outcome Measures
Body composition: fat mass and lean body mass
Myocardial perfusion and glucose uptake, evaluated by positron emission tomography
Secondary Outcome Measures
Heart function evaluated by echocardiography (conventional and tissue doppler)
Lipid profile
24 hour ambulatory blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00420654
Brief Title
Growth Hormone Treatment of Women With Turner Syndrome
Official Title
Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Britta E. Hjerrild
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Turner Syndrome
Keywords
Turner syndrome, growth hormone treatment, positron emission tomography, heart
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Active Comparator
Arm Title
A2
Arm Type
Placebo Comparator
Arm Title
A3
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Growth Hormone
Intervention Description
1.25 mg, 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Equivalent to 1.25 mg, 6 months
Intervention Type
Other
Intervention Name(s)
Healthy controls
Intervention Description
Healthy controls
Primary Outcome Measure Information:
Title
Body composition: fat mass and lean body mass
Time Frame
6 months + 18 months
Title
Myocardial perfusion and glucose uptake, evaluated by positron emission tomography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Heart function evaluated by echocardiography (conventional and tissue doppler)
Time Frame
6 months + 18 months
Title
Lipid profile
Time Frame
6 months + 18 months
Title
24 hour ambulatory blood pressure
Time Frame
6 months + 18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens S. Christiansen, prof. dr.med
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
City
Aarhus
State/Province
DK
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
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Growth Hormone Treatment of Women With Turner Syndrome
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