Diagnostic Accuracy of Bone Turnover Markers and Bone Histology in Patients With CKD Treated by Dialysis

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• 作者：Stuart M. Sprague ; DO¹ ; ^{stuartmsprague@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Ezequiel Bellorin-Font ; MD² ; Vanda Jorgetti ; MD ; PhD³ ; Aluizio B. Carvalho ; MD ; PhD⁴ ; Hartmut H. Malluche ; MD⁵ ; Aní ; bal Ferreira ; MD ; PhD⁶ ; Patrick C. D&rsquo ; Haese ; PhD⁷ ; Tilman B. Drü ; eke ; MD⁸ ; Hongyan Du ; MB ; MS¹ ; Thomas Manley ; RN ; CRNA⁹ ; Eudocia Rojas ; MD² ; Sharon M. Moe ; MD¹⁰
• 关键词：Sensitivity and specificity ; alkaline phosphatases ; bone-specific alkaline phosphatase (bALP ; BSAP) ; bone histomorphometry ; chronic kidney disease&ndash ; mineral bone disorder (CKD-MBD) ; parathyroid hormone (PTH) ; procollagen type 1 N propeptide (P1NP) ; renal osteodystrophy
• 刊名：American Journal of Kidney Diseases
• 出版年：2016
• 出版时间：April 2016
• 年：2016
• 卷：67
• 期：4
• 页码：559-566
• 全文大小：389 K

文摘

The management of chronic kidney disease–mineral and bone disorder requires the assessment of bone turnover, which most often is based on parathyroid hormone (PTH) concentration, the utility of which remains controversial.

Study Design

Cross-sectional retrospective diagnostic test study.

Setting & Participants

492 dialysis patients from Brazil, Portugal, Turkey, and Venezuela with prior bone biopsy and stored (−20°C) serum.

Index Tests

Samples were analyzed for PTH (intact [iPTH] and whole PTH), bone-specific alkaline phosphatase (bALP), and amino-terminal propeptide of type 1 procollagen (P1NP).

Reference Test

Bone histomorphometric assessment of turnover (bone formation rate/bone surface [BFR/BS]) and receiver operating characteristic curves for discriminating diagnostic ability.

Results

The biomarkers iPTH and bALP or combinations thereof allowed discrimination of low from nonlow and high from nonhigh BFR/BS, with an area under the receiver operating characteristic curve > 0.70 but < 0.80. Using iPTH level, the best cutoff to discriminate low from nonlow BFR/BS was <103.8 pg/mL, and to discriminate high from nonhigh BFR/BS was >323.0 pg/mL. The best cutoff for bALP to discriminate low from nonlow BFR/BS was <33.1 U/L, and for high from nonhigh BFR/BS, 42.1 U/L. Using the KDIGO practice guideline PTH values of greater than 2 but less than 9 times the upper limit of normal, sensitivity and specificity of iPTH level to discriminate low from nonlow turnover bone disease were 65.7% and 65.3%, and to discriminate high from nonhigh were 37.0% and 85.8%, respectively.

Limitations

Cross-sectional design without consideration of therapy. Potential limited generalizability with samples from 4 countries.

Conclusions

The serum biomarkers iPTH, whole PTH, and bALP were able to discriminate low from nonlow BFR/BS, whereas iPTH and bALP were able to discriminate high from nonhigh BFR/BS. Prospective studies are required to determine whether evaluating trends in biomarker concentrations could guide therapeutic decisions.