Genotonorm
Drug0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
NCT Number: NCT01073605
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
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Notify Me3 year–12 year
All sexes
Interventional
Phase 3
Pfizer Investigational Site, Angers, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
Time frame: Baseline, 2 years
Annual growth rate was expressed as height velocity (centimeter [cm]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx - Height Y{x-1}) / {(Date of Yx - Date of Y{x-1}) /365.25}
Time frame: Baseline, 1 to 6 years
Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.
Time frame: Baseline, 1 to 3 years
Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.
Time frame: Baseline, 1 to 6 years, final height
Performed by use of a wallmounted device (eg, Harpenden Stadiometer). Each subject was measured 3 times and the mean of these measurements was recorded as the present height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.
Time frame: Baseline, 1 to 6 years, final height
Calculated by substracting height at Baseline from height at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.
Time frame: Baseline, 1 to 6 years, final height
Calculated using Sempe reference means and standard deviations for height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.
Time frame: Baseline, 1 to 6 years, final height
Calculated by substracting height SDS at Baseline from height SDS at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.
Time frame: Baseline, 1 to 6 years
BMI was calculated by weight divided by height squared.
Time frame: Baseline, 1 to 6 years
Time frame: Baseline, 1 to 3 years
Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year
Time frame: 1 to 3 years
Bone age was determined by the Greulich-Pyle method. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. Chronological Age used was the age at the date that the corresponding Bone Age X-ray was performed. Ratio was calculated by change from Baseline in bone age divided by change from Baseline in chronological age.
Time frame: Onset of puberty
Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.
Time frame: Baseline, 1 to 6 years
The defined criteria for reaching puberty were: boy=if right or left testes volume ≥4 ml; girl=if breast development ≥2. Tanner Adolescent Pubertal Staging Questionnaire documents the stage of development of secondary sexual characteristics rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Onset of puberty was defined as the visit where the data recorded first met the above criteria for starting puberty.
Pfizer
Industry
A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation
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