Cholecalciferol Supplementation Attenuates Bone Loss in Incident Kidney Transplant Recipients: A Prespecified Secondary Endpoint Analysis of a Randomized Controlled Trial

Tsujita, Makoto; Doi, Yohei; Obi, Yoshitsugu; Hamano, Takayuki; Tomosugi, Toshihide; Futamura, Kenta; Okada, Manabu; Hiramitsu, Takahisa; Goto, Norihiko; Isaka, Yoshitaka; Takeda, Asami; Narumi, Shunji; Watarai, Yoshihiko

doi:https://doi.org/10.1002/jbmr.4469

Cholecalciferol Supplementation Attenuates Bone Loss in Incident Kidney Transplant Recipients: A Prespecified Secondary Endpoint Analysis of a Randomized Controlled Trial

Tsujita, Makoto; Doi, Yohei; Obi, Yoshitsugu et al.

Journal of Bone and Mineral Research, 2022, 37(2), 303-311

アクセス数:1,341件（2025-09-12 08:47 集計）

固定URL: https://hdl.handle.net/11094/92481

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タイトル	Cholecalciferol Supplementation Attenuates Bone Loss in Incident Kidney Transplant Recipients: A Prespecified Secondary Endpoint Analysis of a Randomized Controlled Trial
著者	著者名 Tsujita, Makoto
	NRID 1000030846382 1000030846382 ORCID 0000-0002-5165-291X 0000-0002-5165-291X researchmap permalink DOI-YOHEI DOI-YOHEI 著者名 Doi, Yohei
	著者名 Obi, Yoshitsugu
	著者名 Hamano, Takayuki
	著者名 Tomosugi, Toshihide
	著者名 Futamura, Kenta
	著者名 Okada, Manabu
	著者名 Hiramitsu, Takahisa
	著者名 Goto, Norihiko
	NRID 1000000379166 1000000379166 researchmap permalink isaka-handai3857 isaka-handai3857 Scopus Author ID 16207611100 16207611100 ORCID 0000-0002-0820-7167 0000-0002-0820-7167 著者名 Isaka, Yoshitaka
	著者名 Takeda, Asami
	著者名 Narumi, Shunji
	著者名 Watarai, Yoshihiko
キーワード等	BONE MINERAL DENSITY
	CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDER
	KIDNEY TRANSPLANTATION
	PARATHYROID HORMONE
	VITAMIN D
内容	Tsujita M., Doi Y., Obi Y., et al. Cholecalciferol Supplementation Attenuates Bone Loss in Incident Kidney Transplant Recipients: A Prespecified Secondary Endpoint Analysis of a Randomized Controlled Trial. Journal of Bone and Mineral Research 37, 303 (2022); https://doi.org/10.1002/jbmr.4469.
抄録	Vitamin D deficiency, persistent hyperparathyroidism, and bone loss are common after kidney transplantation (KTx). However, limited evidence exists regarding the effects of cholecalciferol supplementation on parathyroid hormone (PTH) and bone loss after KTx. In this prespecified secondary endpoint analysis of a randomized controlled trial, we evaluated changes in PTH, bone metabolic markers, and bone mineral density (BMD). At 1 month post-transplant, we randomized 193 patients to an 11-month intervention with cholecalciferol (4000 IU/d) or placebo. The median baseline 25-hydroxyvitamin D (25[OH]D) level was 10 ng/mL and 44% of participants had osteopenia or osteoporosis. At the end of the study, the median 25(OH)D level was increased to 40 ng/mL in the cholecalciferol group and substantially unchanged in the placebo group. Compared with placebo, cholecalciferol significantly reduced whole PTH concentrations (between-group difference of −15%; 95% confidence interval [CI] −25 to −3), with greater treatment effects in subgroups with lower 25(OH)D, lower serum calcium, or higher estimated glomerular filtration rate (pint < 0.05). The percent change in lumbar spine (LS) BMD from before KTx to 12 months post-transplant was −0.2% (95% CI −1.4 to 0.9) in the cholecalciferol group and −1.9% (95% CI −3.0 to −0.8) in the placebo group, with a significant between-group difference (1.7%; 95% CI 0.1 to 3.3). The beneficial effect of cholecalciferol on LS BMD was prominent in patients with low bone mass pint < 0.05). Changes in serum calcium, phosphate, bone metabolic markers, and BMD at the distal radius were not different between groups. In mediation analyses, change in whole PTH levels explained 39% of treatment effects on BMD change. In conclusion, 4000 IU/d cholecalciferol significantly reduced PTH levels and attenuated LS BMD loss after KTx. This regimen has the potential to eliminate vitamin D deficiency and provides beneficial effects on bone health even under glucocorticoid treatment. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
出版者	John Wiley and Sons Inc
収録物名	Journal of Bone and Mineral Research
巻(号)	37(2)
ページ	303-311
刊行年月	2022-02-01
言語	英語
ハンドルURL	https://hdl.handle.net/11094/92481
PISSN	08840431
eISSN	15234681
NCID	AA12479704
関連情報 (isIdenticalTo)	DOI (出版社版) https://doi.org/10.1002/jbmr.4469
アクセス権	open access
権利情報	This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
権利情報	© 2021 Tsujita M., et al. Journal of Bone and Mineral Researchpublished by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research(ASBMR).
出版タイプ	Version of Record
カテゴリ	学術雑誌論文 Journal Article

資源タイプ	学術雑誌論文
ローカル資源タイプ	学術雑誌論文
DCMI資源タイプ	text
DCTERMS.bibliographicCitation	Journal of Bone and Mineral Research. 2022, 37(2), p. 303-311
DC.title	Cholecalciferol Supplementation Attenuates Bone Loss in Incident Kidney Transplant Recipients: A Prespecified Secondary Endpoint Analysis of a Randomized Controlled Trial
DC.creator	Tsujita, Makoto
	Doi, Yohei
	Obi, Yoshitsugu
	Hamano, Takayuki
	Tomosugi, Toshihide
	Futamura, Kenta
	Okada, Manabu
	Hiramitsu, Takahisa
	Goto, Norihiko
	Isaka, Yoshitaka
	Takeda, Asami
	Narumi, Shunji
	Watarai, Yoshihiko
DC.publisher	John Wiley and Sons Inc
DC.language' scheme='DCTERMS.RFC1766	英語
DC.type' scheme='DCTERMS.DCMIType	text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2022-02-01
DC.identifier	https://doi.org/10.1002/jbmr.4469
DC.subject	BONE MINERAL DENSITY
	CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDER
	KIDNEY TRANSPLANTATION
	PARATHYROID HORMONE
	VITAMIN D
DC.description	Tsujita M., Doi Y., Obi Y., et al. Cholecalciferol Supplementation Attenuates Bone Loss in Incident Kidney Transplant Recipients: A Prespecified Secondary Endpoint Analysis of a Randomized Controlled Trial. Journal of Bone and Mineral Research 37, 303 (2022); https://doi.org/10.1002/jbmr.4469.
DCTERMS.abstract	Vitamin D deficiency, persistent hyperparathyroidism, and bone loss are common after kidney transplantation (KTx). However, limited evidence exists regarding the effects of cholecalciferol supplementation on parathyroid hormone (PTH) and bone loss after KTx. In this prespecified secondary endpoint analysis of a randomized controlled trial, we evaluated changes in PTH, bone metabolic markers, and bone mineral density (BMD). At 1 month post-transplant, we randomized 193 patients to an 11-month intervention with cholecalciferol (4000 IU/d) or placebo. The median baseline 25-hydroxyvitamin D (25[OH]D) level was 10 ng/mL and 44% of participants had osteopenia or osteoporosis. At the end of the study, the median 25(OH)D level was increased to 40 ng/mL in the cholecalciferol group and substantially unchanged in the placebo group. Compared with placebo, cholecalciferol significantly reduced whole PTH concentrations (between-group difference of −15%; 95% confidence interval [CI] −25 to −3), with greater treatment effects in subgroups with lower 25(OH)D, lower serum calcium, or higher estimated glomerular filtration rate (pint < 0.05). The percent change in lumbar spine (LS) BMD from before KTx to 12 months post-transplant was −0.2% (95% CI −1.4 to 0.9) in the cholecalciferol group and −1.9% (95% CI −3.0 to −0.8) in the placebo group, with a significant between-group difference (1.7%; 95% CI 0.1 to 3.3). The beneficial effect of cholecalciferol on LS BMD was prominent in patients with low bone mass pint < 0.05). Changes in serum calcium, phosphate, bone metabolic markers, and BMD at the distal radius were not different between groups. In mediation analyses, change in whole PTH levels explained 39% of treatment effects on BMD change. In conclusion, 4000 IU/d cholecalciferol significantly reduced PTH levels and attenuated LS BMD loss after KTx. This regimen has the potential to eliminate vitamin D deficiency and provides beneficial effects on bone health even under glucocorticoid treatment. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
DC.rights	This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
DC.rights	© 2021 Tsujita M., et al. Journal of Bone and Mineral Researchpublished by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research(ASBMR).
DC.format	92481
citation_title	Cholecalciferol Supplementation Attenuates Bone Loss in Incident Kidney Transplant Recipients: A Prespecified Secondary Endpoint Analysis of a Randomized Controlled Trial
citation_author	Tsujita, Makoto
	Doi, Yohei
	Obi, Yoshitsugu
	Hamano, Takayuki
	Tomosugi, Toshihide
	Futamura, Kenta
	Okada, Manabu
	Hiramitsu, Takahisa
	Goto, Norihiko
	Isaka, Yoshitaka
	Takeda, Asami
	Narumi, Shunji
	Watarai, Yoshihiko
citation_publisher	John Wiley and Sons Inc
citation_language	英語
citation_date	2022-02-01
citation_journal_title	Journal of Bone and Mineral Research
citation_volume	37
citation_issue	2
citation_firstpage	303
citation_lastpage	311
citation_doi	https://doi.org/10.1002/jbmr.4469
citation_public_url	https://hdl.handle.net/11094/92481

Cholecalciferol Supplementation Attenuates Bone Loss in Incident Kidney Transplant Recipients: A Prespecified Secondary Endpoint Analysis of a Randomized Controlled Trial

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