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

Number of Access:1,341（2025-09-12 08:40 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/92481

Link to primary information

File	Format	Terms of use	Size	Views	Date.Available	Description	information
JBoneMinerRes_37_2_303	pdf	None	1.31 MB	275	2023.09.04

Creative Commons : Attribution - NonCommercial

Item Information

Output File Export EndNote Basic Export Mendeley

Title	Cholecalciferol Supplementation Attenuates Bone Loss in Incident Kidney Transplant Recipients: A Prespecified Secondary Endpoint Analysis of a Randomized Controlled Trial
Creator	CreatorName Tsujita, Makoto
	NRID 1000030846382 1000030846382 ORCID 0000-0002-5165-291X 0000-0002-5165-291X researchmap permalink DOI-YOHEI DOI-YOHEI CreatorName Doi, Yohei
	CreatorName Obi, Yoshitsugu
	CreatorName Hamano, Takayuki
	CreatorName Tomosugi, Toshihide
	CreatorName Futamura, Kenta
	CreatorName Okada, Manabu
	CreatorName Hiramitsu, Takahisa
	CreatorName 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 CreatorName Isaka, Yoshitaka
	CreatorName Takeda, Asami
	CreatorName Narumi, Shunji
	CreatorName Watarai, Yoshihiko
Subject	BONE MINERAL DENSITY
	CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDER
	KIDNEY TRANSPLANTATION
	PARATHYROID HORMONE
	VITAMIN D
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.
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).
Publisher	John Wiley and Sons Inc
Source Title	Journal of Bone and Mineral Research
Volume (Issue)	37(2)
Page	303-311
Date of Issued	2022-02-01
Language	English
Handle URL	https://hdl.handle.net/11094/92481
PISSN	08840431
eISSN	15234681
NCID	AA12479704
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1002/jbmr.4469
Access Rights	open access
CopyRight	This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
CopyRight	© 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).
oaire:version	Version of Record
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 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	English
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	English
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

Link to primary information

Item Information

Show details