Failure to Thrive
Conditions
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.
Interventions
DRUGSomatropin (rDNA origin) for injection
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed