Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Overall Status

Completed

CT.gov ID

NCT00004275

Collaborator

Jefferson Medical College of Thomas Jefferson University (Other)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Turner's Syndrome	Drug: growth hormone Drug: oxandrolone	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turner's Syndrome

Study Start Date :

Oct 1, 1999

Actual Primary Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 14 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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