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Completed

NCT Number: NCT01073605

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

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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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Endocrine disease except well-substituted hypothyroidism
  • Sever chronic disease
  • Skeletal dysplasia
  • Known chromosomal aberration
  • Ongoing treatment with steroids
  • Known intrauterine infection

Treatment and study plan

Genotonorm

Drug

0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection

Primary outcomes

  1. 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}

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Body Mass Index (BMI)

    Time frame: Baseline, 1 to 6 years

    BMI was calculated by weight divided by height squared.

  8. Weight

    Time frame: Baseline, 1 to 6 years

  9. 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

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
1993
Primary completion
2009
Study completion
2009
First posted
Feb 23, 2010
Registry last updated
Nov 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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