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

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ClinicalTrials.gov Identifier: NCT00163189
Recruitment Status : Completed
First Posted : September 13, 2005
Results First Posted : June 25, 2015
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: Somatropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm
Study Start Date : January 2005
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: Somatropin Drug: Somatropin
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163189


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00163189    
Other Study ID Numbers: A6281271
2004-002992-17 ( EudraCT Number )
First Posted: September 13, 2005    Key Record Dates
Results First Posted: June 25, 2015
Last Update Posted: June 25, 2015
Last Verified: June 2015