Growth Hormone Treatment of Women With Turner Syndrome

November 6, 2011 updated by: Britta E. Hjerrild

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • DK
      • Aarhus, DK, Denmark, 8000
        • Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body composition: fat mass and lean body mass
Time Frame: 6 months + 18 months
6 months + 18 months
Myocardial perfusion and glucose uptake, evaluated by positron emission tomography
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart function evaluated by echocardiography (conventional and tissue doppler)
Time Frame: 6 months + 18 months
6 months + 18 months
Lipid profile
Time Frame: 6 months + 18 months
6 months + 18 months
24 hour ambulatory blood pressure
Time Frame: 6 months + 18 months
6 months + 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Britta E. Hjerrild

Investigators

  • Principal Investigator: Jens S. Christiansen, prof. dr.med, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 6, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-BH-GH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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