Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
- Registration Number
- NCT00163189
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Somatropin Somatropin -
- Primary Outcome Measures
Name Time Method Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population 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 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
Name Time Method Mean Height 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) 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) 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) 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.
Body Mass Index (BMI) 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).
Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) 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.
Change From Baseline in Height at Month 12, 24, 36, 48 and 60 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 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 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 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) 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.
Trial Locations
- Locations (19)
Centre de Perharidy
🇫🇷Roscoff Cedex, France
Hôpital Lenval
🇫🇷Nice, France
CHU Timone Enfants
🇫🇷Marseille Cedex 5, France
Hôpital Arnaud De Villeneuve
🇫🇷Montpellier, France
CHU Tours - Centre Pediatrique Gatien de Cocheville
🇫🇷Tours Cedex 1, France
CHU de Nantes, Hôpital Mère Enfant
🇫🇷Nantes cedex 1, France
CHU Charles Nicolle
🇫🇷Rouen Cedex, France
CHU de Grenoble, Hôpital Couple enfant.
🇫🇷Grenoble Cedex 9, France
Hôpital Robert Debré
🇫🇷Paris, France
Hôpital des Enfants
🇫🇷Toulouse Cedex 9, France
Hôpital Saint Jacques
🇫🇷Besancon Cedex, France
Hôpital Nord
🇫🇷Amiens, France
Groupe hospitalier Est-Hôpital Femme, Mère, Enfant
🇫🇷Bron, France
Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pédiatrie et Néonatologie
🇫🇷Annemasse Cedex, France
Groupe hospitalier Est- Hôpital Femme, Mère, Enfant
🇫🇷Bron, France
CHU d'Estaing
🇫🇷Clermont-Ferrand Cedex 1, France
Hôpital Armand Trousseau
🇫🇷Paris, France
Service de Pédiatrie- Centre Hospitalier Intercommunal
🇫🇷Saint Germain-en-Laye Cedex, France
Groupe Hospitalier Necker - Enfants Malades
🇫🇷Paris cedex 15, France