Clinical Trial: Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)
Brief Summary: 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.
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome: Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Eli Lilly and Company
Dates:
Date Received: September 12, 2005
Date Started: February 2000
Date Completion:
Last Updated: December 17, 2010
Last Verified: December 2010
