Study type

Study type

Non-interventional study
Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

Evenity

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

328256
Study design details

Main study objective

The overarching objective of this study is to monitor the potential risk of serious infection (SI) associated with the use of romosozumab in comparison with other available osteoporosis (OP) medications in routine clinical practice in Europe.

Outcomes

Serious infection (SI) leading to hospitalization, Death due to Serious infection (SI), operationalized as either of:- In-hospital death with a diagnosis of infection during the same admission/episode- Recorded diagnosis of any infection followed by death in the subsequent month

Data analysis plan

Incidence rates and 95 % confidence intervals (CIs) for Serious Infection (SI) events 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 key SI risk factors. 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 (SI leading to hospitalization and SI leading to death) 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 %.