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

NCT ID: NCT00001343

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1992-12-11
• Study Completion Date: 2007-10-10

Brief 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.

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.

Conditions

Dwarfism; Turner's Syndrome

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Humatrope

Intervention Type: DRUG

Oxandrolone

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: lead

Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

Palmer CG, Reichmann A. Chromosomal and clinical findings in 110 females with Turner syndrome. Hum Genet. 1976 Dec 29;35(1):35-49. doi: 10.1007/BF00295617.

Reference Type: BACKGROUND

PMID: 1002163 (View on PubMed)

Other Identifiers

93-CH-0054

Identifier Type: -

Identifier Source: secondary_id

930054

Identifier Type: -

Identifier Source: org_study_id