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Trial record 1 of 1 for:    NCT00174187
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Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

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ClinicalTrials.gov Identifier: NCT00174187
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 15, 2005
Results First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Results First Submitted Date  ICMJE September 11, 2012
Results First Posted Date  ICMJE December 4, 2012
Last Update Posted Date December 4, 2012
Study Start Date  ICMJE September 2000
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2012)
  • Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3 [ Time Frame: Baseline, Year 3 ]
    Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
  • Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height [ Time Frame: Baseline, when final height was reached (assessed up to Year 11) ]
    Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
  • Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height [ Time Frame: Baseline, when final height was reached (assessed up to Year 11) ]
    Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
  • Puberty Stage at Final Height [ Time Frame: When final height was reached (assessed up to Year 11) ]
    Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
The main efficacy criteria assess the effects on linear growth of Genotonorm
Change History Complete list of historical versions of study NCT00174187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2012)
  • Bone Age [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.
  • Lean Body Mass [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.
  • Annual Percent Change in Lean Body Mass at Year 1, 2 and 3 [ Time Frame: Baseline, Year 1, 2, 3 ]
    Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100.
  • Percent Change From Baseline in Lean Body Mass at Year 3 [ Time Frame: Baseline, Year 3 ]
    Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100.
  • Lean Body Mass as Percentage of Total Weight [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    Lean body mass, a measurement of body composition, was assessed by DEXA scan.
  • Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
  • Fat Mass [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    Fat mass, a measurement of body composition, was assessed by DEXA scan.
  • Annual Percent Change in Fat Mass at Year 1, 2 and 3 [ Time Frame: Baseline, Year 1, 2, 3 ]
    Fat mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100.
  • Percent Change From Baseline in Fat Mass at Year 3 [ Time Frame: Baseline, Year 3 ]
    Fat mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100.
  • Fat Mass as Percentage of Total Weight [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    Fat mass, a measurement of body composition, was assessed by DEXA scan.
  • Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    Fat mass was assessed by DEXA scan. Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
  • Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS]) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    BMAD (LS) was assessed by DEXA scan.
  • Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA]) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
  • Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage]) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
  • Bone Mineral Density of Total Body (BMD [TB]) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    BMD (TB) was assessed by DEXA scan.
  • Bone Mineral Density of Lumbar Spine (BMD [LS]) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    BMD (LS) was assessed by DEXA scan.
  • Bone Mineral Content of Total Body (BMC [TB]) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    DEXA scan of BMC was used to evaluate potential bone effects of treatment. BMC is an estimate of the amount of mineral (such as calcium) in the bone.
  • Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3 [ Time Frame: Baseline, Year 1, 2, 3 ]
    BMC is an estimate of the amount of mineral (such as calcium) in the bone. Annual percent change: (BMC [TB] at current year minus BMC [TB] at previous year) divided by BMC [TB] at previous year, multiplied by 100.
  • Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3 [ Time Frame: Baseline, Year 3 ]
    BMC is an estimate of the amount of mineral (such as calcium) in the bone. Percent change: (BMC [TB] at Year 3 minus BMC [TB] at baseline) divided by BMC [TB] at baseline, multiplied by 100.
  • Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA]) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
  • Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage]) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
The other efficacy evaluated criteria are the effect of Genotonorm on bone metabolism and body composition. The absorptiometry will evaluate the bone mineralisation and the body composition (lean mass, fat mass) at the inclusion visit and every year duri
Current Other Pre-specified Outcome Measures
 (submitted: November 5, 2012)
  • Growth Velocity (GV) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    Growth velocity measures the annual rate of increase in height.
  • Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA]) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    GV measures the annual rate of increase in height. GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
  • Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA]) [ Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ]
    GV measures the annual rate of increase in height. GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
  • Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3 [ Time Frame: Baseline, Year 1, 2, 3 ]
  • Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3 [ Time Frame: Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11) ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy
Official Title  ICMJE Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety.
Brief Summary
  • To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
  • To assess the effect of a long term treatment with Genotonorm on bone mineralisation
  • To assess the effect of a long term treatment with Genotonorm on body composition
Detailed Description This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endocrine System Diseases
Intervention  ICMJE Drug: Somatropin
liquid, daily, until final height 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 * David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: September 9, 2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children with juvenile arthritis or nephrotic syndrome
  • Before or during puberty

Exclusion Criteria:

  • Diabetes Type 1 and 2
  • Endocrine disease, except well substituted hypothyroidism
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 17 Years   (Child)
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 NCT00174187
Other Study ID Numbers  ICMJE 307-MET-9002-0009
A6281016
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 November 2012

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