Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis

Ebina, Kosuke; Tsuboi, Hideki; Nagayama, Yoshio; Kashii, Masafumi; Kaneshiro, Shoichi; Miyama, Akira; Nakaya, Hiroyuki; Kunugiza, Yasuo; Hirao, Makoto; Okamura, Gensuke; Etani, Yuki; Takami, Kenji; Goshima, Atsushi; Miura, Taihei; Nakata, Ken; Okada, Seiji

doi:https://doi.org/10.1016/j.jbspin.2021.105219

Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis

Ebina, Kosuke; Tsuboi, Hideki; Nagayama, Yoshio et al.

Joint Bone Spine, 2021, 88(5), 105219

Number of Access:1,600（2025-07-24 10:25 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/93243

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Title	Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis
Creator	NRID 1000070612076 1000070612076 researchmap permalink k-ebina k-ebina Scopus Author ID 8415453300 8415453300 ORCID 0000-0002-2426-1024 0000-0002-2426-1024 CreatorName Ebina, Kosuke
	CreatorName Tsuboi, Hideki
	CreatorName Nagayama, Yoshio
	CreatorName Kashii, Masafumi
	CreatorName Kaneshiro, Shoichi
	CreatorName Miyama, Akira
	CreatorName Nakaya, Hiroyuki
	NRID 1000060507193 1000060507193 CreatorName Kunugiza, Yasuo
	CreatorName Hirao, Makoto
	CreatorName Okamura, Gensuke
	NRID 1000060898930 1000060898930 CreatorName Etani, Yuki
	CreatorName Takami, Kenji
	CreatorName Goshima, Atsushi
	CreatorName Miura, Taihei
	NRID 1000000283747 1000000283747 researchmap permalink ken-nakata ken-nakata Scopus Author ID 7402151308 7402151308 CreatorName Nakata, Ken
	NRID 1000030448435 1000030448435 ORCID 0000-0002-5107-8209 0000-0002-5107-8209 researchmap permalink okadaseiji okadaseiji Scopus Author ID 35079139100 35079139100 CreatorName Okada, Seiji
Subject	Bone turnover marker
	Postmenopausal osteoporosis
	Predictor
	Prior treatment
	Romosozumab
Description	Ebina K., Tsuboi H., Nagayama Y., et al. Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis. Joint Bone Spine 88, 105219 (2021); https://doi.org/10.1016/j.jbspin.2021.105219.
Abstract	Objectives: To investigate the effects of prior treatment and determine the predictors of a 12-month treatment response of romosozumab (ROMO) in 148 patients with postmenopausal osteoporosis. Methods: In this prospective, observational, and multicenter study, treatment naïve patients (Naïve; n = 50) or patients previously treated with bisphosphonates (BP; n = 37) or denosumab (DMAb; n = 45) or teriparatide (TPTD; n = 16) (mean age, 75.0 years; T-scores of the lumbar spine [LS] −3.2 and total hip [TH] −2.6) were switched to ROMO due to insufficient effects of prior treatment. Bone mineral density (BMD) and serum bone turnover markers were evaluated for 12 months. Results: At 12 months, changes in LS BMD were Naïve (18.2%), BP (10.2%), DMAb (6.4%), and TPTD (11.2%) (P < 0.001 between groups) and changes in TH BMD were Naïve (5.6%), BP (3.3%), DMAb (0.6%), and TPTD (4.4%) (P < 0.01 between groups), respectively. In all groups, the LS BMD significantly increased from baseline at 6 and 12 months, although only the DMAb group failed to obtain a significant increase in TH BMD during 12-month treatment. Mean values of N-terminal type I procollagen propeptide (PINP; μg/L) from baseline → 1 month → 12 months were Naïve (67.9 → 134.1 → 51.0), BP (32. 2 → 81.7 → 40.9), DMAb (30.4 → 56.2 → 75.3), and TPTD (97.4 → 105.1 → 37.1), and those of isoform 5b of tartrate-resistant acid phosphatase (TRACP-5b; mU/dL) were Naïve (500.4 → 283.8 → 267.1), BP (273.4 → 203.1 → 242.0), DMAb (220.3 → 246.1 → 304.8), and TPTD (446.6 → 305.1 → 235.7), respectively. Multiple regression analysis revealed that the significant predictors of BMD change at 12 months were difference of prior treatment (r = −2.8, P < 0.001) and value of PINP at 1 month (r = 0.04, P < 0.01) for LS, and difference of prior treatment (r = −1.3, P < 0.05) and percentage change of TRACP-5b at 1 month (r = −0.06, P < 0.05) for TH. Conclusions: The early effects of ROMO on LS and TH BMD increase at 12 months were significantly affected by the difference of prior treatment and are predicted by the early change in bone turnover markers.
Publisher	Elsevier
Source Title	Joint Bone Spine
Volume (Issue)	88(5)
Page	105219
Date of Issued	2021-10-01
Language	English
Handle URL	https://hdl.handle.net/11094/93243
PISSN	1297319X
eISSN	17787254
Relation.isVersionOf	DOI (Publisher Version) https://doi.org/10.1016/j.jbspin.2021.105219
Access Rights	open access
CopyRight	© 2021. This manuscript version is made available under the CC-BY-NC-ND 4.0 license
oaire:version	Accepted Manuscript
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
DCMI Type	Text
DCTERMS.bibliographicCitation	Joint Bone Spine. 2021, 88(5), p. 105219
DC.title	Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis
DC.creator	Ebina, Kosuke
	Tsuboi, Hideki
	Nagayama, Yoshio
	Kashii, Masafumi
	Kaneshiro, Shoichi
	Miyama, Akira
	Nakaya, Hiroyuki
	Kunugiza, Yasuo
	Hirao, Makoto
	Okamura, Gensuke
	Etani, Yuki
	Takami, Kenji
	Goshima, Atsushi
	Miura, Taihei
	Nakata, Ken
	Okada, Seiji
DC.publisher	Elsevier
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2021-10-01
DC.identifier	https://doi.org/10.1016/j.jbspin.2021.105219
DC.subject	Bone turnover marker
	Postmenopausal osteoporosis
	Predictor
	Prior treatment
	Romosozumab
DC.description	Ebina K., Tsuboi H., Nagayama Y., et al. Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis. Joint Bone Spine 88, 105219 (2021); https://doi.org/10.1016/j.jbspin.2021.105219.
DCTERMS.abstract	Objectives: To investigate the effects of prior treatment and determine the predictors of a 12-month treatment response of romosozumab (ROMO) in 148 patients with postmenopausal osteoporosis. Methods: In this prospective, observational, and multicenter study, treatment naïve patients (Naïve; n = 50) or patients previously treated with bisphosphonates (BP; n = 37) or denosumab (DMAb; n = 45) or teriparatide (TPTD; n = 16) (mean age, 75.0 years; T-scores of the lumbar spine [LS] −3.2 and total hip [TH] −2.6) were switched to ROMO due to insufficient effects of prior treatment. Bone mineral density (BMD) and serum bone turnover markers were evaluated for 12 months. Results: At 12 months, changes in LS BMD were Naïve (18.2%), BP (10.2%), DMAb (6.4%), and TPTD (11.2%) (P < 0.001 between groups) and changes in TH BMD were Naïve (5.6%), BP (3.3%), DMAb (0.6%), and TPTD (4.4%) (P < 0.01 between groups), respectively. In all groups, the LS BMD significantly increased from baseline at 6 and 12 months, although only the DMAb group failed to obtain a significant increase in TH BMD during 12-month treatment. Mean values of N-terminal type I procollagen propeptide (PINP; μg/L) from baseline → 1 month → 12 months were Naïve (67.9 → 134.1 → 51.0), BP (32. 2 → 81.7 → 40.9), DMAb (30.4 → 56.2 → 75.3), and TPTD (97.4 → 105.1 → 37.1), and those of isoform 5b of tartrate-resistant acid phosphatase (TRACP-5b; mU/dL) were Naïve (500.4 → 283.8 → 267.1), BP (273.4 → 203.1 → 242.0), DMAb (220.3 → 246.1 → 304.8), and TPTD (446.6 → 305.1 → 235.7), respectively. Multiple regression analysis revealed that the significant predictors of BMD change at 12 months were difference of prior treatment (r = −2.8, P < 0.001) and value of PINP at 1 month (r = 0.04, P < 0.01) for LS, and difference of prior treatment (r = −1.3, P < 0.05) and percentage change of TRACP-5b at 1 month (r = −0.06, P < 0.05) for TH. Conclusions: The early effects of ROMO on LS and TH BMD increase at 12 months were significantly affected by the difference of prior treatment and are predicted by the early change in bone turnover markers.
DC.rights	© 2021. This manuscript version is made available under the CC-BY-NC-ND 4.0 license
DC.format	93243
citation_title	Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis
citation_author	Ebina, Kosuke
	Tsuboi, Hideki
	Nagayama, Yoshio
	Kashii, Masafumi
	Kaneshiro, Shoichi
	Miyama, Akira
	Nakaya, Hiroyuki
	Kunugiza, Yasuo
	Hirao, Makoto
	Okamura, Gensuke
	Etani, Yuki
	Takami, Kenji
	Goshima, Atsushi
	Miura, Taihei
	Nakata, Ken
	Okada, Seiji
citation_publisher	Elsevier
citation_language	English
citation_date	2021-10-01
citation_journal_title	Joint Bone Spine
citation_volume	88
citation_issue	5
citation_firstpage	105219
citation_doi	https://doi.org/10.1016/j.jbspin.2021.105219
citation_public_url	https://hdl.handle.net/11094/93243

Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis

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