Glucocorticoid-induced osteoporosis (GIOP): prescription patterns of glucocorticoids in paediatric patients

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (H02A) CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN

  CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
• Medical condition to be studied:
  Osteoporotic fracture

Population studied

• Short description of the study population:
  Patients with ages between 0 and 17 between 2015 and 2020 were included. All data from IMS FR and primary care data and paediatric speciality data from IMS DE were used.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  2500000

Study design details

• Main study objective:
  Can a sufficient number of paediatric patients exposed to long term prescription of glucocorticoid-containing products, and that develop fractures, be identified to suggest that recruitment for a clinical trial in GIOP is feasible?
• Outcomes:
  Osteoporosis and/or fractures
• Data analysis plan:
  A descriptive analysis of ten disorders likely to lead to long-term exposure to glucocorticoids was developed. Yearly prevalence of glucocorticoids was determined. Distribution of number of prescriptions of glucocorticoids per child was estimated. Incidence rates of osteoporosis and or fracture in patients taking more than four prescriptions of glucocorticoids in a 180-day window were calculated.