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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00266656
First received: December 15, 2005
Last updated: October 10, 2014
Last verified: October 2014
  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.


Condition Intervention Phase
Turner Syndrome
Drug: Somatropin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Adult height at the end of growth. [ Time Frame: Protocol completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height SDS at various ages. [ Time Frame: Over course of the study ] [ Designated as safety issue: No ]
  • Age at attainment of Tanner 2 breast development. [ Time Frame: Over course of the study ] [ Designated as safety issue: No ]
  • Chronological age at first visit subject attained bone age of 14.5 years [ Time Frame: Protocol completion ] [ Designated as safety issue: No ]
  • Reports of serious adverse events. [ Time Frame: Over course of the study ] [ Designated as safety issue: Yes ]
  • Occurrence of pre-specified clinically relevant events. [ Time Frame: Over course of the study ] [ Designated as safety issue: Yes ]
  • Tympanometry and audiometry results for assessment of middle ear function and hearing. [ Time Frame: Over course of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: December 2005
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control
Experimental: 2
Humatrope
Drug: Somatropin
According to investigator's clinical practice and guided by the approved package insert
Other Names:
  • LY137998
  • Humatrope
  • Growth hormone

  Eligibility

Ages Eligible for Study:   4 Years to 20 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266656

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

Locations
United States, California
Childrens Hospital of Los Angeles Active, not recruiting
Los Angeles, California, United States, 90027
United States, Colorado
Children's Hospital Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact    860-545-8362      
Principal Investigator: Karen Rubin         
United States, Illinois
Children's Hospital of Chicago Research Center Active, not recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
Riley Hosptial for Children Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Missouri
Children's Mercy Hospital Active, not recruiting
Kansas City, Missouri, United States, 64108
United States, North Carolina
University of NC at Chapel Hill School of Medicine Active, not recruiting
Chapel Hill, North Carolina, United States, 275999
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact    215-955-1648      
Principal Investigator: Judith Ross         
United States, Washington
Childrens Hospital and Medical Center Active, not recruiting
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00266656     History of Changes
Other Study ID Numbers: 10088, B9R-US-GDGH
Study First Received: December 15, 2005
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Turner Syndrome
Syndrome
Adnexal Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Chromosome Disorders
Congenital Abnormalities
Disease
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Ovarian Diseases
Pathologic Processes
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Urogenital Abnormalities
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014