Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
- Conditions
- Growth DisordersIntrauterine Growth Retardation
- Interventions
- Drug: Genotonorm
- Registration Number
- NCT01073605
- Lead Sponsor
- Pfizer
- Brief Summary
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- Chronological age (CA) between 3 and 10 for girls
- Chronological age between 3 and 12 for boys
- Height for CA below - 2 SD
- Birth length for CA below -2SD
- Endocrine disease except well-substituted hypothyroidism
- Sever chronic disease
- Skeletal dysplasia
- Known chromosomal aberration
- Ongoing treatment with steroids
- Known intrauterine infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Genotonorm A Genotonorm Continuous 0.7 IU/kg/week or 0.03 mg/kg/day Genotonorm B Genotonorm Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day Genotonorm C Genotonorm Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day
- Primary Outcome Measures
Name Time Method Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm 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}
- Secondary Outcome Measures
Name Time Method Annual Growth Rate Standard Deviation Score (SDS) 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.
Change From Baseline in Annual Growth Rate SDS 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.
Height (cm) 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.
Change From Baseline in Height (cm) 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.
Height (SDS) 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.
Change From Baseline in Height (SDS) 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.
Body Mass Index (BMI) Baseline, 1 to 6 years BMI was calculated by weight divided by height squared.
Weight Baseline, 1 to 6 years Change From Baseline in Bone Age 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
Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio 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.
Chronological Age at Onset of Puberty 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.
Number of Subjects Reaching Puberty 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇫🇷Vandoeuvre Les Nancy Cedex, France