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The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome

Information source: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dwarfism; Turner's Syndrome

Intervention: Humatrope (Drug); Oxandrolone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Summary

Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities. This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination. All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone. The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn.

Clinical Details

Official title: The Relative Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate, GH Binding Protein, IGF-I, and Cognitive Function in Growth Hormone-Treated Girls With Turner Syndrome

Study design: Primary Purpose: Treatment

Detailed description: Turner syndrome is associated with short stature, multiple physical stigmata, and absent pubertal development. We propose to: (1) examine the effects of sex steroids (androgen) on multiple variables (growth rate, GH binding protein, IGF-I, and cognitive function), in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination on the above variables.

Eligibility

Minimum age: 10 Years. Maximum age: 14 Years. Gender(s): Female.

Criteria:

- INCLUSION CRITERIA:

Girls with Turner syndrome will qualify to participate in this study if they meet the following criteria: Karyotype diagnosis compatible with Turner syndrome. No treatment with estrogen, androgen or growth hormone exceeding twelve months, and no treatment with either of these agents in the preceding 3 months. Chronological age of 10. 0 to 14. 9 years. Bone age less than or equal to 12 years. EXCLUSION CRITERIA: Prior treatment with estrogen, androgen, or growth hormone for more than twelve months. Y component in peripheral karyotype.

Locations and Contacts

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland 20892, United States

Thomas Jefferson University, Philadelphia, Pennsylvania 19107-6541, United States

Additional Information

Related publications:

Palmer CG, Reichmann A. Chromosomal and clinical findings in 110 females with Turner syndrome. Hum Genet. 1976 Dec 29;35(1):35-49.

Starting date: December 1992
Last updated: November 25, 2009

Page last updated: August 23, 2015

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