Romosozumab (EVENITY®) Disease area studied Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available) Osteoporosis A study to learn how romosozumab worked in women with osteoporosis who had gone through menopause Phase 3 20070337 Completed NCT015758342011-001456-11 LINKLINK PDF Cosman, N Engl J Med 2016; 375(16):1532–43 Cosman, Journal of bone and mineral research 2018; 33(7):1219–26 Cosman, J Bone Miner Res 2018; 33(8):1407–16 Lewiecki EM, J Bone Miner Res 2019; 34(3):419–28 McCloskey, Osteoporos Int 2021; 32(8):1601-1608 Miyauchi, Arch Osteoporos 2019; 14(1):59 Chavassieux, Journal of bone and mineral research 2019; 34(9):1597–608 Miyauchi Journal of bone and mineral metabolism 2021; 39(2):278–88 Lane N.E. et al. ACR open rheumatology 2024; 6(1):43–51 Osteoporosis A study to learn how romosozumab worked in women with osteoporosis who had gone through menopause Phase 3 20110142 Completed NCT016312142011-003142-41 LINKLINK PDF Saag et al NEJM 2017, 377(15):1417-1427 Brown, J Bone Miner Res 2021, 36(11):2139-2152 Cosman, J Bone Miner Res 2020; 35(7):1333–42 Osteoporosis A study to learn how romosozumab worked in men with osteoporosis Phase 3 20110174 Completed NCT02186171 LINKLINK PDF Lewiecki et al., Journal of clinical endocrinology and metabolism 2018; 103(9):3183–93 Osteoporosis A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis Phase 3 OP0002 Completed NCT05067335 LINK Osteoporosis postmenopausal European non-interventional post-authorization safety study related to serious cardiovascular events of myocardial infarction and stroke, and all-cause mortality for romosozumab by the EU-ADR Alliance N/A OP0004 Ongoing EUPAS35881 Osteoporosis postmenopausal European non-interventional post-authorization safety study related to adherence to the risk minimization measures for romosozumab by the EU-ADR Alliance N/A OP0005 Ongoing EUPAS35956 Osteoporosis postmenopausal European non-interventional post-authorization safety study related to serious infections for romosozumab by the EU-ADR Alliance N/A OP0006 Ongoing EUPAS36005
