This study is a randomized, open-label, active controlled, parallel group study comparing the efficacy and safety of once weekly Somatrogon to daily Growth Hormone (Genotropin) in pre-pubertal children with short stature either born Small for Gestational Age (SGA) or with Idiopathic Short Stature (ISS). The planned study duration is 12 months with a screening period of up to 30 days. The study will consist of two groups: 140 children with SGA who are naïve to GH treatment will be randomized 1:1 to receive either Somatrogon or Genotropin for 12 months. A second group will include 114 children with ISS who are naïve to GH treatment who will be randomized 1:1 to receive either Somatrogon or Genotropin for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
254
Once weekly Growth Hormone
Daily Growth Hormone
Schneider Children Medical Center- the institute of Endocrinology and Diabetes
Petah Tikva, Israel, Israel
Shaare Zedek Medical Center
Jerusalem, Israe, Israel
Soroka hospital
Bear Sheva, Israel
Sheba Medical Center
Ramat Gan, Israel
Assaf Harofe Medical Center
Rishon LeZiyyon, Israel
Dana-Duek children's hospital
Tel Aviv, Israel
Annual Height Velocity
Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.
Time frame: • Annualized HV after 12 months of treatment
Height Velocity over time
Time frame: HV over 3, 6 and 9 months
height SDS
Changes in height Standard Deviation Score (SDS)
Time frame: 3, 6, 9 and 12 months
Bone maturation
Annual change in bone age measurements as per Gruelich-Pyle method
Time frame: at screening and after 12 months
Insulin-like Growth Factor-1 (IGF-1)
Via central lab analysis
Time frame: Screening and after 3, 6, 9 and 12 months
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS)
Via central lab analysis
Time frame: Baseline and at 12 months
change in health-related quality of life
Assessed by QoLISSY questionnaire
Time frame: baseline and after 12 months
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