和田　圭司    Department   Other, Other    Position
Article types	Original article
Language	English
Peer review	Peer reviewed
Title	Early clinical effects, safety, and predictors of the effects of romosozumab treatment in osteoporosis patients: one-year study.
Journal	Formal name：Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA Abbreviation：Osteoporos Int ISSN code：14332965/0937941X
Domestic / Foregin	Foregin
Volume, Issue, Page	32(10),pp.1999-2009
Author and coauthor	TOMINAGA Ayako, WADA Keiji, OKAZAKI Ken, NISHI Hideharu, TERAYAMA Yasushi, KATO Yoshiharu
Authorship	2nd author
Publication date	2021/10
Summary	Romosozumab is an effective treatment for spine osteoporosis because it reduces the incidence of new fractures and significantly increases the percent change in the spine BMD at 12 months. The percent change in the spine BMD is higher in patients not previously treated with other anti-osteoporosis medications.INTRODUCTION:Romosozumab appeared as a new osteoporosis medication in Japan in 2019. It is an anti-sclerostin antibody, which increases bone formation and suppresses bone resorption. The aim of our study was to elucidate the clinical effects, safety, and predictors of the effects of one-year romosozumab treatment.METHODS:This study was an observational study designed as a pre-post study in 262 patients. Romosozumab (210 mg) was administered subcutaneously once every 4 weeks during 12 months. We focused on incidence of new fractures, safety, bone mineral density (BMD) at the spine and total hip, and bone metabolism markers.RESULTS:There were five cases of new fractures during one-year romosozumab treatment. There were no fatal adverse events. Percent changes from baseline in the spine and total hip BMD after 12 months of romosozumab treatment were 10.67% and 2.04%, respectively. Romosozumab had better effects in cases of severe osteoporosis with low spine BMD, high TRACP-5b, and high iP1NP at the start of romosozumab treatment. The percent change in the spine BMD at 12 months was significantly lower in the group transitioning from bisphosphonates than in the group not previously treated with other anti-osteoporosis medications.CONCLUSION:Romosozumab is an effective treatment for spine osteoporosis because it significantly increases the percent change in the spine BMD at 12 months. The percent change in the spine BMD is higher in patients not previously treated with other anti-osteoporosis medications.
DOI	10.1007/s00198-021-05925-3
PMID	33770201