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Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
This study is currenly Recruiting patients.
Sponsored by:
Eli Lilly and Company
Purpose
This is an extension study that will gather long-term data on the effect of early growth
hormone (GH) treatment on adult height and other aspects of health and development in girls
with Turner syndrome. The main purpose is to determine whether girls who received 2 years of
GH treatment before 6 years of age achieve taller adult height than girls who were untreated
during this time. The study will also look at middle ear and hearing function, and cognitive
and behavioral development. Protocol completion is defined as attainment of height velocity
less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.
Study Type: Intervention
| Condition | Intervention | Phase |
|
Turner Syndrome |
Drug: Somatropin | Phase 4 |
Study Design:Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Official Title: Effect of Early Growth Hormone Treatment on Long-term Growth and Skeletal Maturation in Girls With Turner Syndrome
Further Study Details:
Expected Total Enrollment:
Study Dates:December 2005 -
Eligibility
Ages Eligible for Study- Min: 4 Years Max: 20 Years
Gender: Female
Criteria
Inclusion Criteria:
Previously randomized in study B9R-US-GDFG
Karyotype-proven Turner syndrome
Exclusion Criteria:
Immediate family members of study site personnel directly affiliated with the study
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier: NCT00266656
California
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 90027
Colorado
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. - Aurora, Colorado 80045
Connecticut
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 06106
Illinois
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 60614
Indiana
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 46202
Missouri
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 64108
North Carolina
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. - Chapel Hill, North Carolina 275999
Pennsylvania
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 19107
More Information
Record Last Reviewed:July 2010
Last Updated:July 9, 2010
Record First Recieved:December 15, 2005
ClinicalTrials.gov Identifier:NCT00266656
Health Authority: United States Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 08, 2010
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