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

Phase 3 Completed 98 enrolled Pfizer

NaSingle-groupOpen-labelTreatment

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

Timeline

Start: 2005-01
Primary completion: 2014-12
Completion: 2014-12

Outcome

Met primary endpoint

registry analysis (unspecified test); Genotonorm; p <0.001; Student's paired t-test NCT00163189 ↗

registry analysis (unspecified test); Genotonorm; p = 0.008; Student's paired t-test NCT00163189 ↗

paper Primary analysis of change in SDS for height for CA from baseline to M36 showed a significant increase of 0.80±1.03. PMID 30910221 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Somatropin	Protein / enzyme biologic	0.46 mg/kg	—