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Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
This study has been completed.

First Received on September 12, 2005.   Last Updated on December 17, 2010   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00190658
  Purpose

This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a somatropin-treated group of girls with Turner syndrome. After the second year patients in the control group have the option to receive treatment as well. All patients will optionally be treated until they achieved adult height.


Condition Intervention Phase
Failure to Thrive
 Drug: Somatropin (rDNA origin) for injection
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome persistent Müllerian duct syndrome pseudoachondroplasia tetrasomy 18p Turner syndrome Help Me Understand Genetics
MedlinePlus related topics: Turner Syndrome
Drug Information available for: Somatropin Somatotropin
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.

Secondary Outcome Measures:
  • Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
  • Non inferiority to somatropin treated patients with Turner syndrome
  • Adult height of treated patients

Estimated Enrollment: 75
Study Start Date: February 2000
Study Completion Date: September 2010
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Turner Syndrome or SHOX disorder
  • SHOX: bone age greater than 10 years for boys, greater than 8 years for girls, Turner: bone age greater than 9 years
  • Height below 3rd percentile or height below 10th percentile and growth velocity below 25th percentile
  • Prepubertal: For girls, Tanner stage 1, for boys Tanner stage 1 and testicular volume no more than 2 mL

Exclusion Criteria:

  • GH deficiency or known insensitivity
  • Evidence of tumor activity
  • Diabetes mellitus or history of impaired glucose tolerance
  • Any severe illness known to interfere growth
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190658

Locations
United States, 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, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00190658     History of Changes
Other Study ID Numbers: 2704, B9R-MC-GDFN
Study First Received: September 12, 2005
Last Updated: December 17, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Failure to Thrive
Turner Syndrome
Growth Disorders
Pathologic Processes
Gonadal Dysgenesis
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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