Diagnostic Accuracy of Noninvasive Bone Turnover Markers in Renal Osteodystrophy,American Journal of Kidney Diseases

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Diagnostic Accuracy of Noninvasive Bone Turnover Markers in Renal Osteodystrophy
American Journal of Kidney Diseases ( IF 9.4 ) Pub Date : 2021-10-26 , DOI: 10.1053/j.ajkd.2021.07.027
Hanne Skou Jørgensen ₁ , Geert Behets ₂ , Liesbeth Viaene ₃ , Bert Bammens ₄ , Kathleen Claes ₄ , Bjorn Meijers ₄ , Maarten Naesens ₄ , Ben Sprangers ₄ , Dirk Kuypers ₄ , Etienne Cavalier ₅ , Patrick D'Haese ₂ , Pieter Evenepoel ₄

Affiliation

Rationale & Objective

Bone biopsy remains the gold standard for diagnosing renal osteodystrophy as comparable noninvasive alternatives have yet to be established. This study investigated the diagnostic accuracy of biochemical markers of skeletal remodeling to predict bone turnover.

Study Design

Cross-sectional retrospective diagnostic test study.

Setting & Participants

Patients with chronic kidney disease glomerular filtration rate categories 4-5, including patients treated with dialysis (G4-G5D) and kidney transplant recipients with successful transiliac bone biopsies.

Tests Compared

Bone turnover as determined by bone histomorphometry was compared with the following biochemical markers: full-length (amino acids 1-84) “biointact” parathyroid hormone (PTH), bone-specific alkaline phosphatase (BsAP), intact procollagen type I N-terminal propeptide (PINP), and tartrate-resistant acid phosphatase isoform 5b (TRAP5b).

Outcome

Diagnostic performance was evaluated by area under the receiver operator characteristics curve (AUC), sensitivity, specificity, and negative and positive predictive values. Optimal diagnostic cutoffs were determined in an exploration cohort (n = 100) and validated in a separate cohort (n = 99).

Results

All biomarkers differed across categories of low 33 (17%), normal 109 (55%), and high 57 (29%) bone turnover. AUC values were in the range of 0.75-0.85. High negative predictive values (≥90%) were found for both high and low bone turnover, indicating the ability to rule out both conditions using the suggested biomarker cutoffs. The highest diagnostic performances were seen with combinations of biomarkers, with overall diagnostic accuracies of 90% for high turnover, and 78% for low turnover. Results were comparable for kidney transplant candidates and recipients in a sensitivity analysis.

Limitations

The single-center approach and heterogeneity of the study cohort are main limitations of this study.

Conclusions

We conclude that the diagnostic performance of biochemical markers of bone turnover is acceptable, with clinical utility in ruling out both high and low turnover bone disease.

中文翻译：

无创骨转换标志物在肾性骨营养不良中的诊断准确性

基本原理和目标

骨活检仍然是诊断肾性骨营养不良的金标准，因为尚未建立类似的非侵入性替代方法。本研究调查了骨骼重塑的生化标志物在预测骨转换方面的诊断准确性。

学习规划

横断面回顾性诊断试验研究。

设置与参与者

慢性肾病肾小球滤过率 4-5 级的患者，包括接受透析治疗的患者 (G4-G5D) 和成功进行经髂骨活检的肾移植受者。

测试比较

将通过骨组织形态学测定的骨转换与以下生化标志物进行比较：全长（氨基酸 1-84）“生物完整”甲状旁腺激素 (PTH)、骨特异性碱性磷酸酶 (BsAP)、完整的 I 型前胶原 N 端前肽 (PINP) 和抗酒石酸酸性磷酸酶异构体 5b (TRAP5b)。

结果

诊断性能通过接受者操作特征曲线下面积（AUC）、敏感性、特异性以及阴性和阳性预测值进行评估。在探索队列（n = 100）中确定最佳诊断截止值，并在单独的队列（n = 99）中验证。

结果

所有生物标志物在低 33 (17%)、正常 109 (55%) 和高 57 (29%) 骨转换类别之间存在差异。AUC 值在 0.75-0.85 范围内。发现高和低骨转换的高阴性预测值 (≥90%)，表明使用建议的生物标志物截止值排除这两种情况的能力。生物标志物组合的诊断性能最高，高周转率的总体诊断准确率为 90%，低周转率的总体诊断准确率为 78%。在敏感性分析中，肾移植候选者和接受者的结果具有可比性。