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Effect of twice-yearly denosumab on prevention of bone mineral density loss in de novo kidney transplant recipients: a randomized controlled trial


Bonani, Marco; Frey, Diana; Brockmann, Jens; Fehr, Thomas; Mueller, Thomas; Saleh, Lanja; von Eckardstein, Arnold; Graf, Nicole; Wüthrich, Rudolf P (2016). Effect of twice-yearly denosumab on prevention of bone mineral density loss in de novo kidney transplant recipients: a randomized controlled trial. American Journal of Transplantation, 16(6):1882-1891.

Abstract

We conducted an open-label, prospective, randomized trial to assess the efficacy and safety of RANKL inhibition with denosumab to prevent the loss of BMD in the first year after kidney transplantation. Ninety kidney transplant recipients were randomized 1:1 two weeks after surgery to receive denosumab (60 mg at baseline and 6 months) or no treatment. After 12 months, total lumbar spine aBMD increased by 4.6% (95% CI 3.3-5.9%) in 46 patients in the denosumab group and decreased by -0.5% (95% CI -1.8-0.9%) in 44 patients in the control group (between-group difference 5.1% (95% CI 3.1-7.0%), P<0.0001). Denosumab also increased aBMD at the total hip by 1.9% (95% CI, 0.1 to 3.7%; P=0.035) over that in the control group at 12 months. HR-pQCT in a subgroup of 24 patients showed that denosumab increased vBMD at the distal tibia and radius (all P<0.05). Biomarkers of bone turnover (β-CTX, P1NP) markedly decreased with denosumab (all P<0.0001). Episodes of cystitis and asymptomatic hypocalcemia occurred more often with denosumab, whereas graft function, rate of rejections and incidence of opportunistic infections were similar. In conclusion, denosumab increased BMD in the first year after kidney transplantation but was associated with more frequent episodes of urinary tract infection. This article is protected by copyright. All rights reserved.

Abstract

We conducted an open-label, prospective, randomized trial to assess the efficacy and safety of RANKL inhibition with denosumab to prevent the loss of BMD in the first year after kidney transplantation. Ninety kidney transplant recipients were randomized 1:1 two weeks after surgery to receive denosumab (60 mg at baseline and 6 months) or no treatment. After 12 months, total lumbar spine aBMD increased by 4.6% (95% CI 3.3-5.9%) in 46 patients in the denosumab group and decreased by -0.5% (95% CI -1.8-0.9%) in 44 patients in the control group (between-group difference 5.1% (95% CI 3.1-7.0%), P<0.0001). Denosumab also increased aBMD at the total hip by 1.9% (95% CI, 0.1 to 3.7%; P=0.035) over that in the control group at 12 months. HR-pQCT in a subgroup of 24 patients showed that denosumab increased vBMD at the distal tibia and radius (all P<0.05). Biomarkers of bone turnover (β-CTX, P1NP) markedly decreased with denosumab (all P<0.0001). Episodes of cystitis and asymptomatic hypocalcemia occurred more often with denosumab, whereas graft function, rate of rejections and incidence of opportunistic infections were similar. In conclusion, denosumab increased BMD in the first year after kidney transplantation but was associated with more frequent episodes of urinary tract infection. This article is protected by copyright. All rights reserved.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Nephrology
04 Faculty of Medicine > University Hospital Zurich > Institute of Clinical Chemistry
04 Faculty of Medicine > University Hospital Zurich > Clinic for Visceral and Transplantation Surgery
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:June 2016
Deposited On:07 Jan 2016 07:46
Last Modified:10 Jul 2016 09:59
Publisher:Wiley-Blackwell Publishing, Inc.
ISSN:1600-6135
Additional Information:This is the peer reviewed version of the following article: Effect of twice-yearly denosumab on prevention of bone mineral density loss in de novo kidney transplant recipients: a randomized controlled trial, which has been published in final form at http://dx.doi.org/10.1111/ajt.13692. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1111/ajt.13692
PubMed ID:26713403

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