Post-marketing Study Assessing the Serious Cardiovascular Events Among Osteoporotic Patients Initiating Romosozumab in Japan Using the Medical Information Database Network (MID-NET) (20190206)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  EVENITY
• Study drug International non-proprietary name (INN) or common name:
  ROMOSOZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (M05BX06) romosozumab

  romosozumab
• Medical condition to be studied:
  Osteoporosis

Population studied

• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  3850

Study design details

• Main study objective:
  The main study objective is to assess the serious cardiovascular events of romosozumab and other osteoporosis medications among osteoporotic patients overall and with/without renal dysfunction in Japan.
• Outcomes:
  Primary outcome:; • Composite endpoint of hospitalized acute myocardial infarction, cerebral hemorrhage and cerebral infarction; ; Secondary outcome:; • Composite endpoint of hospitalized acute myocardial infarction, cerebral hemorrhage and cerebral infarction
• Data analysis plan:
  [Approach to primary objective]; Propensity scores will be calculated for each patient using multiple logistic regression modelling based on baseline demographic characteristics and clinical characteristics. Inverse probability of treatment weights (IPTW) will be created using propensity scores to minimize the measured confounding in the comparison of patients initiating romosozumab relative to patients initiating other specific osteoporosis therapies. Standardized mean differences (SMD) will be used to assess the differences in baseline patient characteristics between the treatment groups. Negative control outcome analyses will be used to detect presence of unmeasured confounding. COX proportional hazards model in the weighted sample will be used to estimate hazard ratio.; ; [Approach to secondary objective]; The same approach will be performed by the level of renal insufficiency.