Growth Hormone Treatment of Women With Turner Syndrome

Not Applicable

Completed

• Conditions: Turner Syndrome
• Interventions: Drug: Growth Hormone; Drug: Placebo; Other: Healthy controls

• Registration Number: NCT00420654
• Lead Sponsor: Britta E. Hjerrild

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

Study Timeline

• Study First Submitted: 2007-01-10
• Study First Submitted QC: 2007-01-10
• Study First Posted: 2007-01-11
• Study Start: 2007-08
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-06
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	Growth Hormone	-
A2	Placebo	-
A3	Healthy controls	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital; 🇩🇰 Aarhus, DK, Denmark