EUROPEAN NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY RELATED TO ADHERENCE TO THE RISK MINIMIZATION MEASURES FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Study drug and medical condition

• Name of medicine:
  EVENITY
• Medical condition to be studied:
  Osteoporosis postmenopausal

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To study the adherence to the risk minimization measures in the product information by estimating the compliance with contraindications and target indication amongst incident romosozumab users, and analyzing the utilization patterns.
• Outcomes:
  Prevalence of contraindications amongst new romosozumab users, - Prevalence of documented indication amongst new romosozumab users- Monthly prevalence of use for each osteoporosis drug- Monthly incidence of use for each osteoporosis drug- Overall duration of treatment/persistence- Proportion persistent at 6, 12, 18, and 24 months- number and percentage of patients who switch to another osteoporosis medication
• Data analysis plan:
  All measures of primary and secondary outcomes will be calculated for each of the contributing databases separately. Estimates will be provided overall (for the whole source population) and stratified by sex (except for use in men), age (5-year bands) and calendar year. Baseline characteristics of all users of romosozumab and of other osteoporosis medications, as well as of romosozumab users in each of the contraindication and restriction of indication groups, will be described.