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

January 10, 2007
November 6, 2011
August 2007
September 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Bodycomposition: fat mass and lean body mass
  • Myocardial perfusion and glucose uptake, evaluated by positron emmision tomography
Complete list of historical versions of study NCT00420654 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Heart function evaluated by echocardiography (conventional and tissue doppler)
  • Lipid profile
  • 24 hour ambulatory bloodpressure
Not Provided
Not Provided
 
Growth Hormone Treatment of Women With Turner Syndrome
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Turner Syndrome
  • Drug: Growth Hormone
    1.25 mg, 6 months
  • Drug: Placebo
    Equivalent to 1.25 mg, 6 months
  • Other: Healthy controls
    Healthy controls
  • Active Comparator: A1
    Intervention: Drug: Growth Hormone
  • Placebo Comparator: A2
    Intervention: Drug: Placebo
  • A3
    Intervention: Other: Healthy controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Female
20 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00420654
2005-BH-GH
Yes
Britta E. Hjerrild, University of Aarhus
Britta E. Hjerrild
Not Provided
Principal Investigator: Jens S. Christiansen, prof. dr.med University of Aarhus
University of Aarhus
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP