Growth Hormone Treatment of Women With Turner Syndrome

Turner Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420654
• Other study ID #: 2005-BH-GH
• Status: Completed
• Phase: N/A
• First received: January 10, 2007
• Last updated: November 6, 2011
• Start date: August 2007
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Intervention

Drug:
• Growth Hormone
1.25 mg, 6 months
• Placebo
Equivalent to 1.25 mg, 6 months

Other:
• Healthy controls
Healthy controls

Locations

Country	Name	City	State
Denmark	Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital	Aarhus	DK

Sponsors (1)

Lead Sponsor	Collaborator
Britta E. Hjerrild

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition: fat mass and lean body mass		6 months + 18 months	No
Primary	Myocardial perfusion and glucose uptake, evaluated by positron emission tomography		6 months	No
Secondary	Heart function evaluated by echocardiography (conventional and tissue doppler)		6 months + 18 months	No
Secondary	Lipid profile		6 months + 18 months	No
Secondary	24 hour ambulatory blood pressure		6 months + 18 months	No