Comparison of the effects of denosumab between a native vitamin D combination and an active vitamin D combination in patients with postmenopausal osteoporosis

Ebina, Kosuke; Kashii, Masafumi; Hirao, Makoto; Hashimoto, Jun; Noguchi, Takaaki; Koizumi, Kota; Kitaguchi, Kazuma; Matsuoka, Hozo; Iwahashi, Toru; Tsukamoto, Yasunori; Yoshikawa, Hideki

doi:https://doi.org/10.1007/s00774-016-0792-5

Comparison of the effects of denosumab between a native vitamin D combination and an active vitamin D combination in patients with postmenopausal osteoporosis

Ebina, Kosuke; Kashii, Masafumi; Hirao, Makoto et al.

Journal of Bone and Mineral Metabolism, 2017, 35(5), 571-580

Number of Access:1,082（2025-09-03 11:38 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/93255

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Title	Comparison of the effects of denosumab between a native vitamin D combination and an active vitamin D combination 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
	NRID 1000000576910 1000000576910 CreatorName Kashii, Masafumi
	NRID 1000010527708 1000010527708 CreatorName Hirao, Makoto
	NRID 1000040237938 1000040237938 CreatorName Hashimoto, Jun
	NRID 1000050812294 1000050812294 researchmap permalink takaakinoguchi takaakinoguchi ORCID 0000-0001-9938-6780 0000-0001-9938-6780 CreatorName Noguchi, Takaaki
	CreatorName Koizumi, Kota
	CreatorName Kitaguchi, Kazuma
	CreatorName Matsuoka, Hozo
	NRID 1000040852108 1000040852108 researchmap permalink tiwa tiwa CreatorName Iwahashi, Toru
	CreatorName Tsukamoto, Yasunori
	NRID 1000060191558 1000060191558 CreatorName Yoshikawa, Hideki
Subject	Alfacalcidol
	Cholecalciferol
	Denosumab
	Postmenopausal osteoporosis
Description	This version of the article has been accepted for publication, after peer review (when applicable) and is subject to Springer Nature’s AM terms of use, but is not the Version of Record and does not reflect post-acceptance improvements, or any corrections. The Version of Record is available online at: https://doi.org/10.1007/s00774-016-0792-5
Description	Ebina K., Kashii M., Hirao M., et al. Comparison of the effects of denosumab between a native vitamin D combination and an active vitamin D combination in patients with postmenopausal osteoporosis. Journal of Bone and Mineral Metabolism 35, 571 (2017); https://doi.org/10.1007/s00774-016-0792-5.
Abstract	The aim of this 12-month, retrospective study was to compare the effects of denosumab (DMAb; 60 mg subcutaneously every 6 months) plus native vitamin D (VD) (cholecalciferol) combination therapy with DMAb plus active VD analog (alfacalcidol) combination therapy in patients with postmenopausal osteoporosis. Patients [N = 127; mean age 75.6 years (range 58–93 years); 28 treatment-naïve patients, 59 patients treated with oral bisphosphonate therapy, 40 patients treated with teriparatide daily] were allocated to either (1) the DMAb plus native VD group (n = 60; cholecalciferol, 10 μg, plus calcium, 610 mg/day; 13 treatment-naïve patients, 28 patients treated with oral bisphosphonate therapy, and 19 patients treated with teriparatide daily) or (2) the DMAb plus active VD group [n = 67; alfacalcidol, 0.8 ± 0.0 μg, plus calcium, 99.2 ± 8.5 mg/day; 15 treatment-naïve patients, 31 patients treated with oral bisphosphonate therapy, and 21 patients treated with teriparatide daily) on the basis of each physician’s decision. Changes in bone mineral density (BMD), serum bone turnover marker levels, and fracture incidence were monitored every 6 months. There were no significant differences in baseline age, BMD, bone turnover marker levels, and prior treatments between the two groups. After 12 months, compared with the DMAb plus native VD group, the DMAb plus active VD group showed similar increases in the BMD of the lumbar spine (6.4% vs 6.5%) and total hip (3.3% vs 3.4%), but significantly greater increases in the BMD of the femoral neck (1.0% vs 4.9%, P < 0.001) and the distal part of the forearm (third of radius) (−0.8% vs 3.9%, P < 0.01). These tendencies were similar regardless of the differences in the prior treatments. The rates of decrease of bone turnover marker levels were similar for tartrate-resistant acid phosphatase isoform 5b (−49.0% vs −49.0%), procollagen type I N-terminal propeptide (−45.9% vs −49.3%), and undercarboxylated osteocalcin (−56.0 vs −66.5%), whereas serum intact parathyroid hormone levels were significantly lower in the DMAb plus active VD group (47.6 pg/mL vs 30.4 pg/mL, P < 0.001). The rate of hypocalcemia was 1.7% in the DMAb plus native VD group and 1.5% in the DMAb plus active VD group, and the rate of clinical fracture incidence was 8.3% in the DMAb plus native VD group and 4.5% in the DMAb plus active VD group, with no significant difference between the groups. DMAb with active VD combination therapy may be a more effective treatment option than DMAb with native VD combination therapy in terms of increasing BMD of the femoral neck and distal part of the forearm and also maintaining serum intact parathyroid hormone at lower levels.
Publisher	Springer Nature
Source Title	Journal of Bone and Mineral Metabolism
Volume (Issue)	35(5)
Page	571-580
Date of Issued	2017-09-01
Language	English
Handle URL	https://hdl.handle.net/11094/93255
PISSN	09148779
eISSN	14355604
Relation.isVersionOf	DOI (Publisher Version) https://doi.org/10.1007/s00774-016-0792-5
Access Rights	open access
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	Journal of Bone and Mineral Metabolism. 2017, 35(5), p. 571-580
DC.title	Comparison of the effects of denosumab between a native vitamin D combination and an active vitamin D combination in patients with postmenopausal osteoporosis
DC.creator	Ebina, Kosuke
	Kashii, Masafumi
	Hirao, Makoto
	Hashimoto, Jun
	Noguchi, Takaaki
	Koizumi, Kota
	Kitaguchi, Kazuma
	Matsuoka, Hozo
	Iwahashi, Toru
	Tsukamoto, Yasunori
	Yoshikawa, Hideki
DC.publisher	Springer Nature
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2017-09-01
DC.identifier	https://doi.org/10.1007/s00774-016-0792-5
DC.subject	Alfacalcidol
	Cholecalciferol
	Denosumab
	Postmenopausal osteoporosis
DC.description	This version of the article has been accepted for publication, after peer review (when applicable) and is subject to Springer Nature’s AM terms of use, but is not the Version of Record and does not reflect post-acceptance improvements, or any corrections. The Version of Record is available online at: https://doi.org/10.1007/s00774-016-0792-5
DC.description	Ebina K., Kashii M., Hirao M., et al. Comparison of the effects of denosumab between a native vitamin D combination and an active vitamin D combination in patients with postmenopausal osteoporosis. Journal of Bone and Mineral Metabolism 35, 571 (2017); https://doi.org/10.1007/s00774-016-0792-5.
DCTERMS.abstract	The aim of this 12-month, retrospective study was to compare the effects of denosumab (DMAb; 60 mg subcutaneously every 6 months) plus native vitamin D (VD) (cholecalciferol) combination therapy with DMAb plus active VD analog (alfacalcidol) combination therapy in patients with postmenopausal osteoporosis. Patients [N = 127; mean age 75.6 years (range 58–93 years); 28 treatment-naïve patients, 59 patients treated with oral bisphosphonate therapy, 40 patients treated with teriparatide daily] were allocated to either (1) the DMAb plus native VD group (n = 60; cholecalciferol, 10 μg, plus calcium, 610 mg/day; 13 treatment-naïve patients, 28 patients treated with oral bisphosphonate therapy, and 19 patients treated with teriparatide daily) or (2) the DMAb plus active VD group [n = 67; alfacalcidol, 0.8 ± 0.0 μg, plus calcium, 99.2 ± 8.5 mg/day; 15 treatment-naïve patients, 31 patients treated with oral bisphosphonate therapy, and 21 patients treated with teriparatide daily) on the basis of each physician’s decision. Changes in bone mineral density (BMD), serum bone turnover marker levels, and fracture incidence were monitored every 6 months. There were no significant differences in baseline age, BMD, bone turnover marker levels, and prior treatments between the two groups. After 12 months, compared with the DMAb plus native VD group, the DMAb plus active VD group showed similar increases in the BMD of the lumbar spine (6.4% vs 6.5%) and total hip (3.3% vs 3.4%), but significantly greater increases in the BMD of the femoral neck (1.0% vs 4.9%, P < 0.001) and the distal part of the forearm (third of radius) (−0.8% vs 3.9%, P < 0.01). These tendencies were similar regardless of the differences in the prior treatments. The rates of decrease of bone turnover marker levels were similar for tartrate-resistant acid phosphatase isoform 5b (−49.0% vs −49.0%), procollagen type I N-terminal propeptide (−45.9% vs −49.3%), and undercarboxylated osteocalcin (−56.0 vs −66.5%), whereas serum intact parathyroid hormone levels were significantly lower in the DMAb plus active VD group (47.6 pg/mL vs 30.4 pg/mL, P < 0.001). The rate of hypocalcemia was 1.7% in the DMAb plus native VD group and 1.5% in the DMAb plus active VD group, and the rate of clinical fracture incidence was 8.3% in the DMAb plus native VD group and 4.5% in the DMAb plus active VD group, with no significant difference between the groups. DMAb with active VD combination therapy may be a more effective treatment option than DMAb with native VD combination therapy in terms of increasing BMD of the femoral neck and distal part of the forearm and also maintaining serum intact parathyroid hormone at lower levels.
DC.format	93255
citation_title	Comparison of the effects of denosumab between a native vitamin D combination and an active vitamin D combination in patients with postmenopausal osteoporosis
citation_author	Ebina, Kosuke
	Kashii, Masafumi
	Hirao, Makoto
	Hashimoto, Jun
	Noguchi, Takaaki
	Koizumi, Kota
	Kitaguchi, Kazuma
	Matsuoka, Hozo
	Iwahashi, Toru
	Tsukamoto, Yasunori
	Yoshikawa, Hideki
citation_publisher	Springer Nature
citation_language	English
citation_date	2017-09-01
citation_journal_title	Journal of Bone and Mineral Metabolism
citation_volume	35
citation_issue	5
citation_firstpage	571
citation_lastpage	580
citation_doi	https://doi.org/10.1007/s00774-016-0792-5
citation_public_url	https://hdl.handle.net/11094/93255

Comparison of the effects of denosumab between a native vitamin D combination and an active vitamin D combination in patients with postmenopausal osteoporosis

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