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.
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.
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