Clinical trial NCT00163189: Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
Official title: Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Deficiency
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population
timeFrame: Baseline, Month 36
measure: Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population
timeFrame: Baseline, Month 36
Secondary outcomes:
measure: Mean Height
timeFrame: Baseline, Month 12, 24, 36, 48, 60
measure: Mean Height Standard Deviation Score (SDS) for Bone Age (BA)
timeFrame: Baseline, Month 12, 24, 36, 48, 60
measure: Annual Growth Rate (AGR)
timeFrame: Baseline, Month 12, 24, 36, 48, 60
measure: Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)
timeFrame: Month 12, 24, 36, 48, 60
measure: Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)
timeFrame: Baseline, Month 12, 24, 36, 48, 60
measure: Body Mass Index (BMI)
timeFrame: Baseline, Month 12, 24, 36, 48, 60
measure: Change From Baseline in Height at Month 12, 24, 36, 48 and 60
timeFrame: Baseline, Month 12, 24, 36, 48, 60
measure: Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60
timeFrame: Baseline, Month 12, 24, 48, 60
measure: Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60
timeFrame: Baseline, Month 12, 24, 36, 48, 60
measure: Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60
timeFrame: Baseline, Month 12, 24, 36, 48, 60
measure: Ratio of Bone Age (BA) to Chronological Age (CA)
timeFrame: Baseline, Month 12, 24, 36, 48, 60
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last study treatment
measure: Number of Participants With Significant Changes in Physical Examinations
timeFrame: Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT)
measure: Number of Participants With at Least 1 Medical or Surgical History
timeFrame: Screening
measure: Number of Participants Who Received Concomitant Medications
timeFrame: Baseline up to Month 60
measure: Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels
timeFrame: Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60
measure: Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60
timeFrame: Screening, Month 12, 24, 36, 48, 60
Locations:
city: Amiens
country: France
facility: Hôpital Nord
city: Annemasse Cedex
country: France
facility: Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pédiatrie et Néonatologie
city: Besancon Cedex
country: France
facility: Hôpital Saint Jacques
city: Bron
country: France
facility: Groupe hospitalier Est- Hôpital Femme, Mère, Enfant
city: Bron
country: France
facility: Groupe hospitalier Est-Hôpital Femme, Mère, Enfant
city: Clermont-Ferrand Cedex 1
country: France
facility: CHU d'Estaing
city: Grenoble Cedex 9
country: France
facility: CHU de Grenoble, Hôpital Couple enfant.
city: Marseille Cedex 5
country: France
facility: CHU Timone Enfants
city: Montpellier
country: France
facility: Hôpital Arnaud De Villeneuve
city: Nantes cedex 1
country: France
facility: CHU de Nantes, Hôpital Mère Enfant
city: Nice
country: France
facility: Hôpital Lenval
city: Paris cedex 15
country: France
facility: Groupe Hospitalier Necker - Enfants Malades
city: Paris
country: France
facility: Hôpital Robert Debré
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Roscoff Cedex
country: France
facility: Centre de Perharidy
city: Rouen Cedex
country: France
facility: CHU Charles Nicolle
city: Saint Germain-en-Laye Cedex
country: France
facility: Service de Pédiatrie- Centre Hospitalier Intercommunal
city: Toulouse Cedex 9
country: France
facility: Hôpital des Enfants
city: Tours Cedex 1
country: France
facility: CHU Tours - Centre Pediatrique Gatien de Cocheville
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.