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 |
"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 2023 [ePub] | |
| 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 |
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 |
LINK LINK |
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 | |||
| 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 |