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Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Turner Syndrome

Intervention: Somatropin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hrs), Study Director, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

Summary

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.

Clinical Details

Official title: Effect of Early Growth Hormone Treatment on Long-term Growth and Skeletal Maturation in Girls With Turner Syndrome

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

Primary outcome: Adult height at the end of growth.

Secondary outcome:

Height SDS at various ages.

Age at attainment of Tanner 2 breast development.

Chronological age at first visit subject attained bone age of 14.5 years

Reports of serious adverse events.

Occurrence of pre-specified clinically relevant events.

Tympanometry and audiometry results for assessment of middle ear function and hearing.

Eligibility

Minimum age: 4 Years. Maximum age: 20 Years. Gender(s): 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

Locations and Contacts

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

Childrens Hospital of Los Angeles, Los Angeles, California 90027, United States; Recruiting
Phone: 323-361-7032
Mitchell Geffner, Principal Investigator

Children's Hospital, Aurora, Colorado 80045, United States; Recruiting
Phone: 720-777-6128
Sharon Travers, Principal Investigator

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Recruiting
Phone: 860-545-8362
Karen Rubin, Principal Investigator

Children's Hospital of Chicago Research Center, Chicago, Illinois 60611, United States; Active, not recruiting

Riley Hosptial for Children, Indianapolis, Indiana 46202, United States; Recruiting
Phone: 317-274-3973
Erica Eugster, Principal Investigator

Children's Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Phone: 816-406-1038
Figen Ugrasbul, Principal Investigator

University of NC at Chapel Hill School of Medicine, Chapel Hill, North Carolina 27514, United States; Active, not recruiting

Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States; Recruiting
Phone: 215-955-1648
Judith Ross, Principal Investigator

Childrens Hospital and Medical Center, Seattle, Washington 98105, United States; Active, not recruiting

Additional Information

Lilly Clinical Trial Registry

Starting date: December 2005
Last updated: August 14, 2015

Page last updated: August 23, 2015

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