To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection
1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)
Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm
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, 2 years
Annual Growth Rate Standard Deviation Score (SDS)
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 6 years
Change From Baseline in Annual Growth Rate SDS
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 3 years
Height (cm)
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
Change From Baseline in Height (cm)
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.
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Pfizer Investigational Site
Angers, France, France
Pfizer Investigational Site
Grenoble, France, France
Pfizer Investigational Site
Paris, France, France
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Amiens, France
Pfizer Investigational Site
Besançon, France
Pfizer Investigational Site
Bordeaux, France
Pfizer Investigational Site
Bordeaux, France
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Boulogne, France
Pfizer Investigational Site
Brest, France
Pfizer Investigational Site
Bron, France
...and 21 more locations
Time frame: Baseline, 1 to 6 years, final height
Height (SDS)
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
Change From Baseline in Height (SDS)
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, final height
Body Mass Index (BMI)
BMI was calculated by weight divided by height squared.
Time frame: Baseline, 1 to 6 years
Weight
Time frame: Baseline, 1 to 6 years
Change From Baseline in Bone Age
Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year
Time frame: Baseline, 1 to 3 years
Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio
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: 1 to 3 years
Chronological Age at 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: Onset of puberty
Number of Subjects Reaching Puberty
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.
Time frame: Baseline, 1 to 6 years