European Program of Post-Authorisation Safety Studies for Protelos®/Osseor® through EU-ADR Alliance
This international study is looking at how women with osteoporosis react to particular medications, with the ultimately goal of improving care to patients.
This is a Post-Authorization Safety Study with a multi-national multi-database approach (population-based cohort study and nested case control analysis in a cohort of new users of strontium ranelate (SR) or oral bisphosphonates).
1. To study the effectiveness of the newly established risk minimization measures by characterizing utilization patterns of SR and estimating the prevalence of contraindications (CI) and restrictions of indication amongst incident and prevalent SR users.
2. To estimate and compare the incidence rates of cardiac and thromboembolic events in new users of SR and new users of bisphosphonates.