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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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 13, 2005
Results First Submitted Date  ICMJE June 1, 2015
Results First Posted Date  ICMJE June 25, 2015
Last Update Posted Date June 25, 2015
Study Start Date  ICMJE January 2005
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Difference between height in sd for chronological age (ca) after 3 years and height in sd for ca at visit 2
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 22, 2015)
  • 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.
  • 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;
  • Number of Participants With at Least 1 Medical or Surgical History [ Time Frame: Screening ]
  • Number of Participants Who Received Concomitant Medications [ Time Frame: Baseline up to Month 60 ]
  • Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels [ Time Frame: Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 ]
  • 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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
Official Title  ICMJE Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Somatropin
Intervention: Drug: Somatropin
Publications * Basmaison O, Ranchin B, Zouater H, Robertson A, Gomez R, Koppiker N. Efficacy and safety of recombinant growth hormone treatment in children with growth retardation related to long-term glucocorticosteroid therapy. Ann Endocrinol (Paris). 2019 Sep;80(4):202-210. doi: 10.1016/j.ando.2019.02.001. Epub 2019 Mar 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2015)
98
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
30
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163189
Other Study ID Numbers  ICMJE A6281271
2004-002992-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP