Denosumab Global Safety Assessment in Multiple Observational Databases (20090522)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources.

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DENOSUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (M05BX04) denosumab

  denosumab
• 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:
  517991

Study design details

• Main study objective:
  Determine incidence rates of adverse events of special interest (AESI) in patients exposed to denosumab, patients exposed to bisphosphonates, and among all women with PMO.
• Outcomes:
  Incidence rates of AESI (per 100,000 Person-years) will be assessed in patients exposed to denosumab, patients exposed to biphosphonates, and among all women with PMO
• Data analysis plan:
  Descriptive statistics will be used to characterize exposure cohorts with respect to patient characteristics, clinical features, and AESI risk factors. Person-year adjusted AESI incidence rates will be calculated among exposure cohorts. Exploratory analyses comparing incidence rates of AESI in women with PMO adjusting for potential confounders will also be conducted. Descriptive statistics will be used to characterize denosumab utilization patterns. Descriptive statistics will be used to characterize patients receiving Prolia for unapproved indications.

Documents

Study results

20090522_ORSR_Abstract_13JUL2023_Redacted2.pdf