The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
318
Subjects with TS will receive SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month
Subjects with GHD will receive SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
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Buenos Aires, Argentina
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Sydney, Australia
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Vienna, Austria
Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1
IGF-1 SDS was calculated using the Elmlinger reference method. Change in within subject IGF-1 levels (standard deviation scores) at Month 1 from Baseline was assessed. Descriptive statistics were determined for the Baseline and Month 1 assessments, and also for the level of change between these two assessments. If either the Baseline or Month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing.
Time frame: Baseline, Month 1
Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1
Time frame: Baseline, Month 1
Change From Baseline in Fasting Glucose Levels at Month 1
Time frame: Baseline, Month 1
Change From Baseline in Fasting Insulin Levels at Month 1
Time frame: Baseline, Month 1
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1
HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter \[pmol/L\]) \* fasting plasma glucose (millimole/liter \[mmol/L\]) divided by 22.5.
Time frame: Baseline, Month 1
Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1
Time frame: Baseline, Month 1
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Mississauga, Canada
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Paris, France
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Munich, Germany
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Rome, Italy
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Oslo, Norway
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Russia, Russia
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Singapore, Singapore
...and 3 more locations