European non-interventional post-authorization safety study related to romosozumab
Description
- Osteoporosis is a disease of the skeletal system that is associated with bone loss and changes in bone structure, leading to an increased risk of fractures. In addition to age and genetic predisposition, risk factors also include sex. Post-menopausal women are particularly affected due to the decrease in estrogen levels.
Romosozumab (Evenity®) is a humanized monoclonal antibody that increases bone formation and inhibits bone resorption. It has been approved in Germany since March 2020 for the treatment of osteoporosis in post-menopausal women at high risk of fracture.
In the clinical trials leading to market approval, cardiovascular events (e.g. myocardial infarction, stroke) were more frequently observed in patients treated with romosozumab than with standard therapy and moreover, serious infections were more frequent in romosozumab users compared to placebo treated patients. Based on these observations, the indication of romosozumab was restricted to women without a history of myocardial infarction or stroke. Additionally, a post-approval safety study (PASS) is conducted as part of the risk management plan by romosozumab manufacturer UCB Pharma GmbH, as an obligation for continued market approval imposed by the European Medicines Agency (EMA).
Based on the German Pharmacoepidemiological Research Database (GePaRD), various endpoints (cardiovascular events such as myocardial infarction, stroke and cardiovascular death, as well as serious infections) and their frequency in romosozumab users will be investigated compared to post-menopausal osteoporotic women who are treated with a different osteoporosis drug. The aforementioned study endpoints as well as the characteristics of the romosozumab users and compliance with the risk minimization measures will be examined in a cohort study with a study period from 2018 to 2023.
This PAS study is part of a consortium of multiple data bases based on data from the Netherlands, Italy, UK, Denmark, Spain, France and Germany. Annual interim reports will be created, the final report is planned for Q4 2026.
Funding period
- Begin: October 2020
End: December 2026
Sponsor
- Pharmaceutical industry
Contact
Project management (international)
- Eva Molero Romen,TEAM-IT Research S.L., Barcelona, Spain