Study type

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

Anatomical Therapeutic Chemical (ATC) code

(M05BX04) 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

508125
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.