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NCT Number: NCT00420654

Growth Hormone Treatment of Women With Turner Syndrome

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.

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Key information

Conditions

Turner Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Male Urogenital Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Urogenital Abnormalities Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital

Aarhus, DK, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

growth hormone

Drug

1.25 mg, 6 months

Placebo

Drug

Equivalent to 1.25 mg, 6 months

Healthy controls

Other

Healthy controls

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Britta E. Hjerrild

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2007
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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