To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Genotropin(somatoropin) 12 mg, Genotropin(somatropin) will be given at a dose of 0.067 mg/kg/day or 0.033 mg/kg/day to all participating patients
University of Occupational and Environmental Health Hospital
Kitakyushu, Fukuoka, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Month 12 (at the end of previous study) to 156
Height Velocity Standard Deviation Score (SDS) for Chronological Age
Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values of the participants age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Time frame: Month 12 (at the end of previous study) to 156
Height Velocity
Height velocity is the yearly height gain
Time frame: Month 12 (at the end of previous study) to 156
Height SDS for Chronological Age
Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values on the participant age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Time frame: Month 12 (at the end of previous study) to 156
Height Velocity SDS for Bone Age
To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
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Hiroshima City Hospital
Hiroshima, Hiroshima, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan
Hokkaido Social Service Association Obihiro Hospital
Obihiro, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
...and 9 more locations
Time frame: Month 12 (at the end of previous study) to 156
Height SDS for Bone Age
To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Time frame: Month 12 (at the end of previous study) to 156