Turner's Syndrome
Conditions
Keywords
Turner's Syndrome, Short Stature, Dwarfism
Brief summary
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.
Interventions
DRUGDA-3002
DRUGGenotropin®
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Turner's Syndrome through chromosome analysis * The chronological age: 2≤AGE≤12 * The yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates * Before the adolescence, Tuner stage I (breast) * Normal thyroid function
Exclusion criteria
* Growth hormone was administered for 12 months or longer in the past * Treated with estrogen or adrenal androgens for 12 months or longer in the past * Malignancy, CNS Trauma, Psychiatric Disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized height velocity(cm/year) after 52 weeks | 52 weeks | Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate |
Secondary
| Measure | Time frame |
|---|---|
| Changes in height standard deviation score after 52 weeks | 52 weeks |
| Changes in bone maturation(changes in bone ages/changes in chronological age) | 52 weeks |
| Changes in IGF-1 | 52 weeks |
| Changes in IGFBP-3 | 52 weeks |
Other
| Measure | Time frame |
|---|---|
| Changes in anti-growth hormone antibody | 52 weeks |
Countries
South Korea
Outcome results
None listed