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EVENITY® (Romosozumab)

 

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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 men with osteoporosis Phase 3 20110174
Completed

NCT02186171
2013-005551-32

LINK
LINK

  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

  Brown, J Bone Miner Res 2021 epub Cosman, J Bone Miner Res 2020; 35(7):1333–42
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

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