Phase 3
Completed N=98
Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
Source: ClinicalTrials.gov NCT00163189 ↗Enrolled (actual)
98
Serious AEs
45.9%
Results posted
Jun 2015
Primary outcomePrimary: 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
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
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 | — |
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
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. Informational only — not medical advice.