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Trial record 7 of 97 for:    "Turner syndrome"
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Growth Hormone Treatment of Women With Turner Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Britta E. Hjerrild, University of Aarhus
ClinicalTrials.gov Identifier:
NCT00420654
First received: January 10, 2007
Last updated: November 6, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Turner Syndrome
 Drug: Growth Hormone
Drug: Placebo
Other: Healthy controls

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.

Resource links provided by NLM:

MedlinePlus related topics: Turner Syndrome
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Body composition: fat mass and lean body mass [ Time Frame: 6 months + 18 months ] [ Designated as safety issue: No ]
  • Myocardial perfusion and glucose uptake, evaluated by positron emission tomography [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart function evaluated by echocardiography (conventional and tissue doppler) [ Time Frame: 6 months + 18 months ] [ Designated as safety issue: No ]
  • Lipid profile [ Time Frame: 6 months + 18 months ] [ Designated as safety issue: No ]
  • 24 hour ambulatory blood pressure [ Time Frame: 6 months + 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: August 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420654

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

No publications provided

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
Study First Received: January 10, 2007
Last Updated: November 6, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Turner syndrome
growth hormone treatment
positron emission tomography
heart

Additional relevant MeSH terms:
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
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
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013