Growth Hormone Treatment of Women With Turner Syndrome

NCT00420654 | Completed DMC

• 1 other identifier: 2005-BH-GH
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Turner Syndrome

Keywords

Turner syndrome; growth hormone treatment; positron emission tomography; heart

Outcome Measures

Primary Outcomes (2)

• Body composition: fat mass and lean body mass

  6 months + 18 months

• Myocardial perfusion and glucose uptake, evaluated by positron emission tomography

  6 months

Secondary Outcomes (3)

• Heart function evaluated by echocardiography (conventional and tissue doppler)

  6 months + 18 months

• Lipid profile

  6 months + 18 months

• 24 hour ambulatory blood pressure

  6 months + 18 months

Study Arms (3)

A1

ACTIVE COMPARATOR

Drug: Growth Hormone

A2

PLACEBO COMPARATOR

Drug: Placebo

A3

OTHER

Other: Healthy controls

Interventions

Growth Hormone DRUG

1.25 mg, 6 months

A1

Placebo DRUG

Equivalent to 1.25 mg, 6 months

A2

Healthy controls OTHER

Healthy controls

A3

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Turner syndrome
• Age 20-40

You may not qualify if:

• Symptomatic heart disease
• Anti hypertensive treatment
• Untreated thyroid disease
• Adipositas (BMI \> 35)
• Treatment with glucocorticoids
• Pregnancy

Sponsors & Collaborators

• Britta E. Hjerrild: lead

Study Sites (1)

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

Aarhus, DK, 8000, Denmark

Location

MeSH Terms

Conditions

Turner Syndrome

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jens S. Christiansen, prof. dr.med

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD Clinical assistent

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 11, 2007
• Study Start: August 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

DK (1)