Phase 3 N=98 Treatment

Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm

Growth Hormone Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT00163189 ↗

Enrolled (actual)

Serious AEs

45.9%

Results posted

Jun 2015

Primary outcome: Primary: Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population — -2.91; 0.80 Standard Deviation Score (SDS) — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Somatropin (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Pfizer
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population	-2.91; 0.80	<0.001 sig
PRIMARY Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population	-2.86; 0.81	0.008 sig
SECONDARY Mean Height	133.9; 139.5; 146.0; 150.4; 152.4; 156.0	—
SECONDARY Mean Height Standard Deviation Score (SDS) for Bone Age (BA)	-0.29; -0.36; 0.11; 0.14; -0.26; -0.19	—
SECONDARY Annual Growth Rate (AGR)	3.0; 6.7; 6.0; 5.9; 4.8; 4.9	—
SECONDARY Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)	-0.13; 0.07; 0.05; -1.00; -0.43	—
SECONDARY Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)	-2.04; 1.77; 5.26; 3.64; 0.93; 1.40	—
SECONDARY Body Mass Index (BMI)	19.4; 19.1; 19.4; 19.4; 19.7; 20.8	—
SECONDARY Change From Baseline in Height at Month 12, 24, 36, 48 and 60	133.9; 6.8; 12.9; 18.8; 23.9; 30.3	—
SECONDARY Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60	-2.91; 0.28; 0.57; 0.82; 0.75	—
SECONDARY Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60	-0.29; -0.02; 0.28; 0.31; -0.08; 0.01	—
SECONDARY Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60	117.9; 17.8; 28.2; 36.5; 52.8; 70.0	—
SECONDARY Ratio of Bone Age (BA) to Chronological Age (CA)	0.78; 0.82; 0.80; 0.79; 0.81; 0.85	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00163189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.