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

• ClinicalTrials.gov Identifier: NCT00001343
• Recruitment Status: Completed
• First Posted: November 4, 1999
• Last Update Posted: July 2, 2017
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by: National Institutes of Health Clinical Center (CC)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dwarfism; Turner's Syndrome	Drug: Humatrope; Drug: Oxandrolone	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 80 participants
• Primary Purpose: Treatment
• 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 Start Date: December 11, 1992
• Study Completion Date: October 10, 2007

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 14 Years (Child)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Maryland

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States, 20892

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107-6541

Sponsors and Collaborators

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

More Information

Publications:

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.

• ClinicalTrials.gov Identifier: NCT00001343
• Other Study ID Numbers: 930054; 93-CH-0054
• First Posted: November 4, 1999
• Last Update Posted: July 2, 2017
• Last Verified: October 10, 2007

Keywords provided by National Institutes of Health Clinical Center (CC):

Turner's Syndrome; Short Stature; Cognitive Function; Sex Steroids; Turner Syndrome; TS

Additional relevant MeSH terms:

Dwarfism; Turner Syndrome; Gonadal Dysgenesis; Syndrome; Disease; Pathologic Processes; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Oxandrolone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists