Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
Status and phase
Completed
Phase 3
Conditions
Failure to Thrive
Treatments
Drug: Somatropin (rDNA origin) for injection
Details and patient eligibility
About
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.
Sex
All
Ages
3+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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