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
RECRUITINGShaare Zedek Medical Center
Jerusalem, Israe, Israel
NOT_YET_RECRUITINGSoroka hospital
Bear Sheva, Israel
NOT_YET_RECRUITINGSheba Medical Center
Ramat Gan, Israel
NOT_YET_RECRUITINGAssaf Harofe Medical Center
Rishon LeZiyyon, Israel
NOT_YET_RECRUITINGDana-Duek children's hospital
Tel Aviv, Israel
NOT_YET_RECRUITINGAnnual 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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