Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome

Phase 3

Completed

• Conditions: Failure to Thrive

• Registration Number: NCT00190658
• Lead Sponsor: Eli Lilly and Company

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 Description

Not available

Study Timeline

• Study Start: 2000-02
• Primary Completion: 2004-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2010-09
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-17
• Last Update Posted: 2010-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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