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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	NCT01575834 2011-001456-11	LINK LINK	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"
Osteoporosis	A study to learn how romosozumab worked in men with osteoporosis	Phase 3	20110174 Completed	NCT02186171	LINK LINK	PDF	Lewiecki et al., Journal of clinical endocrinology and metabolism 2018; 103(9):3183–93
Osteoporosis	A study to learn how romosozumab worked in women with osteoporosis who had gone through menopause	Phase 3	20110142 Completed	NCT01631214 2011-003142-41	LINK LINK	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 Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis	Phase 3	OP0002 Ongoing	NCT05067335
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