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Growth Hormone Treatment of Women With Turner Syndrome

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ClinicalTrials.gov Identifier: NCT00420654
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Turner Syndrome Drug: Growth Hormone Drug: Placebo Other: Healthy controls

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.
Study Start Date : August 2007
Primary Completion Date : September 2011
Study Completion Date : September 2011

Arms and Interventions

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
A3 Other: Healthy controls
Healthy controls

Outcome Measures

Primary Outcome Measures :
  1. Body composition: fat mass and lean body mass [ Time Frame: 6 months + 18 months ]
  2. Myocardial perfusion and glucose uptake, evaluated by positron emission tomography [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Heart function evaluated by echocardiography (conventional and tissue doppler) [ Time Frame: 6 months + 18 months ]
  2. Lipid profile [ Time Frame: 6 months + 18 months ]
  3. 24 hour ambulatory blood pressure [ Time Frame: 6 months + 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420654

Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
Aarhus, DK, Denmark, 8000
Sponsors and Collaborators
Britta E. Hjerrild
Principal Investigator: Jens S. Christiansen, prof. dr.med University of Aarhus
More Information

Responsible Party: Britta E. Hjerrild, MD PhD Clinical assistent, University of Aarhus
ClinicalTrials.gov Identifier: NCT00420654     History of Changes
Other Study ID Numbers: 2005-BH-GH
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Britta E. Hjerrild, University of Aarhus:
Turner syndrome
growth hormone treatment
positron emission tomography

Additional relevant MeSH terms:
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Physiological Effects of Drugs