Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age

Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation.

To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.

Study Overview

• Status: Completed
• Conditions: Fetal Growth Retardation
• Intervention / Treatment: Drug: Genotonorm (Somatropin)

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • ANGERS Cedex 03, France, 49000
    • Pfizer Investigational Site
  • Amiens, France, 80030
    • Pfizer Investigational Site
  • Besançon, France, 25030
    • Pfizer Investigational Site
  • Bordeaux, France, 33000
    • Pfizer Investigational Site
  • Bron Cedex, France, 69677
    • Pfizer Investigational Site
  • Caen Cedex 5, France, 14033
    • Pfizer Investigational Site
  • Dunkerque Cedex 1, France, 59385
    • Pfizer Investigational Site
  • Lille, France, 59019
    • Pfizer Investigational Site
  • Limoges Cedex, France, 87042
    • Pfizer Investigational Site
  • Lorient, France
    • Pfizer Investigational Site
  • Nice, France, 06202
    • Pfizer Investigational Site
  • PARIS Cedex 19, France, 75935
    • Pfizer Investigational Site
  • Paris, France, 75571
    • Pfizer Investigational Site
  • Paris, France, 75743
    • Pfizer Investigational Site
  • Rennes, France, 35203
    • Pfizer Investigational Site
  • Rouen, France, 76000
    • Pfizer Investigational Site
  • Strasbourg, France, 67098
    • Pfizer Investigational Site
  • Tarbes, France, 65000
    • Pfizer Investigational Site
  • Toulouse, France, 31000
    • Pfizer Investigational Site
  • Toulouse, France, 31026
    • Pfizer Investigational Site
  • Tours, France, 37044
    • Pfizer Investigational Site
  • Vandoeuvre Les Nancy, France, 54511
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.
• Measured Height < -2.5 Standard Deviation

Exclusion Criteria:

• Pubertal signs ie: testis volume > or = 4 ml in boys and breast stage > or = B2 (Tanner)
• Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic insufficiency, neoplasia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genotonorm (Somatropin)	Drug: Genotonorm (Somatropin); 0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months	Percentage of children with serum IGF-1 > 2 SD (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. 9 months and 12 months are combined.	9 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	The height in SD was calculated using Sempe reference means and standard deviations for height. Change in height SD was calculated as height in SD at "12 months" minus height in SD at "Baseline".	Baseline, 12 months
Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "24 months" minus height in SD at "Baseline".	Baseline, 24 months
Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 or 24 months" minus height in SD at "Baseline".	Baseline, 12 and 24 months
Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 months" minus height in SD at "Baseline".	Baseline, 12 months
Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "24 months" minus height in SD at "Baseline".	Baseline, 24 months
Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at "12 or 24 months" minus height in SD at "Baseline".	Baseline, 12 and 24 months
Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	Growth rate SD CA at 12 months was calculated as:(Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months Growth rate SD CA at 24 months was calculated as:(Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months	12 and 24 months
Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	Growth rate SD CA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months Growth rate SD CA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months	12 and 24 months
Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for BA at 12 months	Baseline, 12 months
Summary of Growth Rate SD (BA) at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for BA at 24 months	Baseline, 24 months
Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for CA at 12 months Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for CA at 24 months	12 and 24 months
Analysis of Covariance (ANCOVA) for Height SD CA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months	Change in Height SD (CA) was calculated as: Height SD (CA) at 12 months minus Height SD (CA) at Baseline	Baseline, 12 months
ANCOVA for Height SD CA at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months	Height SD (CA) at 24 months.	Baseline, 24 months
ANCOVA for Height SD BA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months	Change in Height SD (BA) was calculated as: Height SD (BA) at 12 months minus Height SD (BA) at Baseline	Baseline, 12 months
ANCOVA for Height SD BA at 24 Months in Children With IGF-1 <= 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months	Height SD (BA) at 24 months	Baseline, 24 months
Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	IGF-1 SD was calculated at each study time point using gender specific IGF-1 reference mean and SD for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 minus reference mean) divided by reference SD	6, 9, 12, 15, 18, 21, and 24 months
Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	IGF-1 SD was calculated at each study time point using these gender specific IGF-1 reference means and SDs for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 - reference mean) / reference SD	6, 9, 12, 15, 18, 21, and 24 months
IGF-1/Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months		12 and 24 months
IGF-1/IGFBP-3 Ratio at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months		12 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Height From Baseline	The standing height measurements were performed at the same time of the day by using a wallmounted device (e.g. Harpenden Stadiometer) at each study visit. The pre-specified clinical outcomes were analyzed at 12 and 24 months.	Baseline, 12 and 24 months
Growth Rate at 12 and 24 Months	Growth Rate was calculated at 12 months as: (Height at 12 months minus Height at Day 0) divided by {(Date of 12 months minus Date of Day 0) divided by 365.25} Growth Rate was calculated at 24 months as: (Height at 24 months minus Height at 12 months) divided by {(Date of 24 months minus Date of 12 months) divided by 365.25}	12 and 24 months
Summary of Body Mass Index (BMI) at 12 and 24 Months	BMI was calculated at 12 months and 24 months as: (Weight at 12 or 24 months divided by Height at 12 or 24 months) squared	12 and 24 months
Change in BA From Baseline at 12 and 24 Months	Change in BA was calculated as: (12 or 24 months minus Screening)	Baseline, 12 and 24 months
BA/CA at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months	The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.	12 and 24 months
BA/CA at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months	The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.	12 and 24 months

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): June 15, 2010
• Last Update Submitted That Met QC Criteria: June 10, 2010
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: A6281234