Growth Hormone Treatment of Women With Turner Syndrome

Study Overview
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Brief Summary
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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
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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

Official Title
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Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.

Conditions
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Turner Syndrome

Intervention / Treatment
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* Drug: Growth Hormone
* Drug: Placebo
* Other: Healthy controls


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Growth Hormone<br>* 1.25 mg, 6 months<br>|
| Placebo Comparator: A2<br> | Drug: Placebo<br>* Equivalent to 1.25 mg, 6 months<br>|
| Other: A3<br> | Other: Healthy controls<br>* Healthy controls<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 |  | 6 months + 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Turner syndrome, growth hormone treatment, positron emission tomography, heart