Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
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

(M05BX) Other drugs affecting bone structure and mineralization
Other drugs affecting bone structure and mineralization

Medical condition to be studied

Osteoporosis postmenopausal
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

337200
Study design details

Main study objective

The overarching objective of this study is to characterize the risk of serious cardiovascular events of myocardial infarction and stroke, and all-cause mortality including cardiovascular death associated with the use of romosozumab, in comparison with other available osteoporosis medications in routine clinical practice in Europe

Outcomes

MACE-2 (first occurrence of death all cause including cardiovascular (CV) death, Myocardial Infarction (MI), or stroke), - Myocardial Infarction (MI)- Stroke- Death due to cardiovascular (CV) causes, ie, MI or stroke- All-cause mortality- First occurrence of death (CV causes), MI, or stroke (MACE-1)

Data analysis plan

Incidence rates and 95 % confidence intervals for each outcome will be calculated for each study drug cohort using a Poisson model. These will be reported for prespecified intervals of 6, 12, 18, and 24 months after treatment indexes, and will be stratified by several factors including age, prior use of osteoporosis medication, and previous history of cardiovascular event. For comparative safety studies, propensity score matching will be used to match patients using romosozumab to up to 3 users of alendronate. Cox regression models stratified by matched sets will be used to calculate hazard ratios and 95 % CIs for each of the safety endpoints (MI, stroke, MACE-1, and MACE-2) according to drug exposure in the propensity-matched cohorts. The pooled estimates of the incidence rate for the databases will be calculated using the random or fixed effects meta-analysis depending on heterogeneity detected using an I^2 threshold of >40 %.