Biochemical Markers of Bone Metabolism and Paget s Disease of Bone

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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.