Clinical Trial: Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation

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 Summary:
Sponsor: Pfizer

Current Primary Outcome: Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm [ 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}


Original Primary Outcome: Change from baseline in annual growth rate (cm/year) measured after 24 months treatment with growth hormone (GH) [ Time Frame: 24 months ]

Current Secondary Outcome:

  • Annual Growth Rate Standard Deviation Score (SDS) [ 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.
  • Change From Baseline in Annual Growth Rate SDS [ 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.
  • Height (cm) [ 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.
  • Change From Baseline in Height (cm) [ 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.
  • Height (SDS) [ 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.
  • Change From Baseline in Height (SDS) [ 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.
  • Body Mass Index (BMI) [ Time Frame: Baseline, 1 to 6 years ]
    BMI was calculated by weight divided by height squared.
  • Weight [ Time Frame: Baseline, 1 to 6 years ]
  • Change From Baseline in Bone Age [ 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
  • Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio [ 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.
  • Chronological Age at Onset of Puberty [ 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.
  • Number of Subjects Reaching Puberty [ 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.


Original Secondary Outcome:

  • Annual growth rate and change in annual growth rate in standard deviation score (SDS) [ Time Frame: every year ]
  • Height measured by use of a wallmonted device and change in height (in cm and SDS) [ Time Frame: every 3 months up to 2 years and amended up to final height ]
  • Weight measured by use of a balanced scale and body mass index (weight divided by height squared) [ Time Frame: every 3 months up to 2 years and amended up to final height ]
  • Bone age measured on an X-ray of the wrist [ Time Frame: every 12 months ]
  • Adverse events obtained by spontaneous reporting by the patient or by active questionning of the investigator [ Time Frame: every 3 months and after GH withdrawal ]
  • Fasting glucose, HbA1c, thyroxine T4 [ Time Frame: Every 12 months ]
  • Pubertal stage measured by testis vomune in boys and breast development in girls [ Time Frame: Every 3 months ]


Information By: Pfizer

Dates:
Date Received: February 22, 2010
Date Started: July 1993
Date Completion:
Last Updated: November 8, 2010
Last Verified: February 2010