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.


Objective: To evaluate safety and efficacy of recombinant human growth hormone treatment in children on long-term glucocorticoid therapy.

Methods: A 5-year prospective open-label study included children on glucocorticoid therapy with either standard deviation score (SDS)<-2 for height for chronological age (CA) if naïve to growth hormone treatment, or annual growth rate≥0 SDS for CA if currently receiving growth hormone.

Results: Ninety-eight patients began treatment, 63 discontinued; 59 were analyzed for safety and 58 for efficacy. There was male predominance (78.0%). Median age was 13.0 years. Median height screening was 136.0cm (range, 95.1-159.7cm). Mean SDS for height for CA in the efficacy analysis set was -2.91±1.19 (range, -7.49 to -0.96). Mean growth hormone dose was 0.4, 0.4, 0.4 and 0.3mg/kg/week at month 0, M12, M24, and M36, respectively. Primary analysis of change in SDS for height for CA from baseline to M36 showed a significant increase of 0.80±1.03. Twenty patients in the safety analysis set had≥1 treatment-emergent adverse event (TEAE) related to study treatment. Two patients experienced serious treatment-related TEAEs: 1 case of poor compliance, and 1 of mild hyperglycemia, both already observed under growth hormone treatment.

Conclusion: This study suggests that growth hormone treatment could be effective in increasing height in children on long-term glucocorticoid treatment with a safety profile comparable to that in approved rhGH treatment indications.

Clinical trial registration: NCT00163189.

Keywords: Croissance; Glucocorticosteroid; Glucocorticoïde; Growth; Growth retardation; Hormone de croissance recombinante; Recombinant growth hormone; Retard de croissance; Traitement; Treatment.

Publication types

  • Clinical Trial

MeSH terms

  • Adolescent
  • Body Height / drug effects
  • Child
  • Child, Preschool
  • Developmental Disabilities / chemically induced
  • Developmental Disabilities / drug therapy
  • Developmental Disabilities / epidemiology
  • Female
  • Glucocorticoids / adverse effects*
  • Glucocorticoids / therapeutic use
  • Growth Disorders / chemically induced*
  • Growth Disorders / drug therapy*
  • Growth Disorders / epidemiology
  • Growth Hormone / therapeutic use*
  • Humans
  • Longitudinal Studies
  • Male
  • Recombinant Proteins / therapeutic use
  • Time Factors
  • Treatment Outcome


  • Glucocorticoids
  • Recombinant Proteins
  • Growth Hormone

Associated data

  • ClinicalTrials.gov/NCT00163189