Bone biopsy, while invasive, is the gold standard for assessing bone status. According to published bone biopsy studies, half of the end-stage renal disease patients have adynamic bone disease. Compared to high-bone-turnover disease, adynamic bone disease has the higher mortality and is associated with arterial calcification. The treatment for high-bone-turnover disease is divergent from the treatment for adynamic bone disease. The parathyroid hormone (PTH) assay has been relied on as the routine, noninvasive diagnostic method to assess bone status. According to bone biopsy studies, the intact PTH assay has been demonstrated as ineffective at differentiating adynamic bone disease from normal and high-bone-turnover disease. For example, bone biopsy studies found the normal range for iPTH to be 451 to 1339 pg/mL and the range for adynamic bone disease to be 400 to 919 pg/mL. Intact PTH measures the sum of the two PTH hormones 1-84 PTH and 7-84 PTH. Specific 1-84 PTH assays neglect the role of the 7-84 PTH hormone, which is to lower bone turnover. According to independent bone biopsy studies, the 1-84 PTH/7-84 PTH ratio is 94% accurate in identifying adynamic bone disease and 94% accurate in assessing bone-turnover status.

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