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OpenTrials
Completed

NCT Number: NCT00163189

Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm

To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Nord, Amiens, 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

  • Glucocorticosteroid treatment for 12 months at least
  • Bone age < 15 years for a boy and < 13 years for a girl
  • Child measured height < - 2 SD, Child currently treated by GH

Exclusion criteria

  • Known diabetes (type 1 or type 2)
  • A previous history of intolerance or hypersensitivity to the study drug or to drugs with similar chemical structures

Treatment and study plan

Somatropin

Drug

Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day

Primary outcomes

  1. Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population

    Time frame: Baseline, Month 36

    Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.

  2. Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population

    Time frame: Baseline, Month 36

    Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.

Secondary outcomes

  1. Mean Height

    Time frame: Baseline, Month 12, 24, 36, 48, 60

    The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.

  2. Mean Height Standard Deviation Score (SDS) for Bone Age (BA)

    Time frame: Baseline, Month 12, 24, 36, 48, 60

    The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.

  3. Annual Growth Rate (AGR)

    Time frame: Baseline, Month 12, 24, 36, 48, 60

    AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). Yx refers to the value at particular timepoint x.

  4. Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)

    Time frame: Month 12, 24, 36, 48, 60

    GR SDS BA Yx = (GR Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand.

  5. Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)

    Time frame: Baseline, Month 12, 24, 36, 48, 60

    GR SDS CA Yx = (GR Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.

  6. Body Mass Index (BMI)

    Time frame: Baseline, Month 12, 24, 36, 48, 60

    BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).

  7. Change From Baseline in Height at Month 12, 24, 36, 48 and 60

    Time frame: Baseline, Month 12, 24, 36, 48, 60

    The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.

  8. Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60

    Time frame: Baseline, Month 12, 24, 48, 60

    The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.

  9. Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60

    Time frame: Baseline, Month 12, 24, 36, 48, 60

    The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.

  10. Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60

    Time frame: Baseline, Month 12, 24, 36, 48, 60

    BA was estimated locally using an X-ray from the left wrist and hand.

  11. Ratio of Bone Age (BA) to Chronological Age (CA)

    Time frame: Baseline, Month 12, 24, 36, 48, 60

    BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.

Other outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Time frame: Baseline up to 28 days after last study treatment

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs include both SAEs and non-SAEs.

  2. Number of Participants With Significant Changes in Physical Examinations

    Time frame: Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT)

    Number of participants with clinically significant physical examinations changes since previous visit were reported. Physical examination including estimation of pubertal stage and blood pressure measurement;

  3. Number of Participants With at Least 1 Medical or Surgical History

    Time frame: Screening

  4. Number of Participants Who Received Concomitant Medications

    Time frame: Baseline up to Month 60

  5. Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels

    Time frame: Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60

  6. Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60

    Time frame: Screening, Month 12, 24, 36, 48, 60

    Fasting and 2 hours plasma glucose levels were assessed using standard oral glucose tolerance test (OGTT).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2005
Registry last updated
Feb 21, 2024

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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