Biochemical Markers of Bone Metabolism and Paget s Disease of Bone

骨代谢的生化指标很容易在血液或尿液样本中测量。识别这些能够检测骨病、与疾病严重程度相关并预测代谢性骨病治疗反应的最佳生物标志物，将是临床医生照顾这些疾病患者的主要优势。最近完成的PRISM和正在进行的PRISM EZ研究提供了一个独特的临床数据集，该数据集涵盖了有史以来作为临床试验一部分治疗的最大的Paget病患者群体。我们将测量从完成PRISM研究的患者和继续使用PRISM EZ的患者中获得的样品中几种新的和已建立的骨代谢生化标志物，并希望确定哪些标志物最能诊断病情，与疾病严重程度相关，预测对治疗的良好反应，治疗失败，无论是在对症治疗组还是强化治疗组，都可以通过对治疗无反应的生物标志物来识别患者，以及这些生物标志物是否比目前使用的标志物（ALP）与临床结果有更好的相关性。确定预测临床结果的生化标志物将有助于早期识别可能对特定治疗方法有反应的患者，从而防止不必要的治疗和宝贵的临床资源的浪费。

Biochemical markers of bone metabolism are easily measured in either blood or urine samples. Identification of the best of these biomarkers that is able to detect bone disease,correlate with severity of disease and predict response to therapy in metabolic bone disease would be a major advantage to clinicians looking after patients with these diseases. The recently completed PRISM and the ongoing PRISM EZ study have provided a unique clinical data set in the largest population of patients with Paget s disease ever treated as part of a clinical trial. We will measure several new and established biochemical markers of bone metabolism in samples obtained from patients who completed the PRISM study and in those continuing within PRISM EZ and hope to identify which marker(s) best diagnose the condition, correlate with disease severity, predict a good response to treatment, failure of treatment, whether within the symptomatic treatment or intensive treatment arms of the trial patients can be identified by biomarkers that are non responders to treatment and whether these biomarkers correlate better than the currently used marker (ALP) with the clinical outcome. Identifying a biochemical marker(s) that predicts clinical outcome would help the early identification of patients who may respond to specific therapeutic approaches that may prevent unnecessary treatment and waste of valuable clinical resources.