Turner's Syndrome
Conditions
Keywords
Turner's syndrome, genetic diseases and dysmorphic syndromes, rare disease
Brief summary
RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may help girls with Turner's syndrome attain a more normal height. It is not yet known if growth hormone is more effective with or without oxandrolone for Turner's syndrome. PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated Turner's syndrome.
Detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to recombinant human growth hormone (GH) and oxandrolone versus GH and placebo. GH is administered by daily subcutaneous injection and oxandrolone is given every day by mouth. Treatment continues for 3 years; estrogen is offered after year 2. A study duration of 8 years is anticipated.
Interventions
DRUGgrowth hormone
DRUGoxandrolone
Sponsors
Jefferson Medical College of Thomas Jefferson University
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: Turner's syndrome-compatible karyotype No Y material in peripheral karyotype Bone age no greater than 11 years --Prior/Concurrent Therapy-- No more than 12 months of prior estrogen, androgen, or growth hormone
Countries
United States
Outcome results
None listed