Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
Completed · Phase 3
Conditions studied: Failure to Thrive
In brief
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.
Key facts
- Study ID
- NCT00190658
- Run by
- Eli Lilly and Company
- People needed
- 75
- Starts
- 2000-02-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2010-12-20
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- GH deficiency or known insensitivity
- Evidence of tumor activity
- Diabetes mellitus or history of impaired glucose tolerance
- Any severe illness known to interfere growth
Where it is running
- 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
Full record on ClinicalTrials.gov
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