The Effect of Growth Hormone in Very Young Girls With Turner Syndrome

Turner Syndrome Clinical Trial

Official title:

The Effect of Recombinant Human Growth Hormone Treatment on the Growth of Infants and Toddlers With Turner Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406926
• Other study ID #: 2878
• Secondary ID: B9R-US-GDFG
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2006
• Last updated: November 29, 2006
• Start date: August 1999
• Est. completion date: August 2003

Study information

• Verified date: November 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study investigated the effect of growth hormone on the growth of infants and toddlers with Turner syndrome during 2 years of treatment with growth hormone. This was compared with the growth of infants and toddlers with Turner syndrome who did not receive any growth hormone treatment. The overall aim was to prevent the growth failure usually seen during this period. The study also looked at middle ear disease, hearing problems, and cognitive and behavioral development.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 9 Months to 4 Years

Eligibility

Inclusion Criteria:

• Karyotype-proven Turner syndrome that included a documented abnormality of the short arm of an X chromosome.

• At least 9 months of age and not greater than 4 years of age.

• Normal values for age for hemoglobin, thyroid stimulating hormone (TSH) and urinalysis (office dipstick is adequate), performed prior to study entry.

• If there was a known history of hypothyroidism, then adequate thyroid hormone replacement must have been taken for at least 6 months prior to study entry.

Exclusion Criteria:

• Current or previous treatment with any therapy that may have directly influenced growth, including growth hormone, growth hormone-releasing hormone, estrogens and anabolic steroids such as oxandrolone. This included previous completion of, or withdrawal from, this study or any other study investigating therapeutic uses of growth hormone or growth hormone-releasing hormone.

• Chronic treatment with systemic glucocorticoids in supra-physiological doses.

• Treatment with potential growth-influencing medications such as methylphenidate (Ritalin), pemoline (Cylert), and amphetamines, at, or within 3 months prior to, study entry.

• Presence of any Y chromosome component in the karyotype if gonads were in situ. Subjects whose karyotype contained Y chromatin, but who had undergone gonadectomy, were eligible to enter the study.

• Presence of any additional known autosomal abnormality.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Intervention

Drug:
• Somatropin

Locations

Country	Name	City	State
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Chicago	Illinois
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Denver	Colorado
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hartford	Connecticut
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Indianapolis	Indiana
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kansas City	Missouri
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lexington	Kentucky
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Los Angeles	California
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Philadelphia	Pennsylvania
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Seattle	Washington
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height at the end of two years in the study.
Secondary	Middle ear problems assessed every 4 months
Secondary	Hearing problems assessed annually
Secondary	Cognitive and behavioral development assessed annually