Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
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.
|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)|
- Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
- 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
|Study Start Date:||February 2000|
|Study Completion Date:||September 2010|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
|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|
|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|