Journal
AMERICAN JOURNAL OF KIDNEY DISEASES
Volume 67, Issue 4, Pages 559-566Publisher
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.ajkd.2015.06.023
Keywords
Sensitivity and specificity; alkaline phosphatases; bone-specific alkaline phosphatase (bALP; BSAP); bone histomorphometry; chronic kidney disease-mineral bone disorder (CKD-MBD); parathyroid hormone (PTH); procollagen type 1 N propeptide (P1NP); renal osteodystrophy
Categories
Funding
- Abbott-AbbVie
- Amgen
- Cytochroma
- Fresenius Medical Care
- Vifor
- Abbott
- Sanofi/Genzyme
- Novartis
- Celgene
- Shire
- Baxter
- Diasorin
- Chugai
- Kirin
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Background: 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 degrees 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. (C) 2016 by the National Kidney Foundation, Inc.
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