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

NCT00001343 | Completed Phase 2

• 2 other identifiers: 93005493-CH-0054
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Dwarfism; Turner's Syndrome

Keywords

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

Interventions

Humatrope DRUG

Oxandrolone DRUG

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Prior treatment with estrogen, androgen, or growth hormone for more than twelve months.
• Y component in peripheral karyotype.

Sponsors & Collaborators

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

Study Sites (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-6541, United States

Location

Related Publications (1)

• 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.

  PMID: 1002163 BACKGROUND

MeSH Terms

Conditions

Dwarfism; Turner Syndrome

Interventions

Human Growth Hormone; Oxandrolone

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Gonadal Dysgenesis; 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; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: December 11, 1992
• Study Completion: October 10, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-10-10

Locations

US (2)