A new serum assay to measure N-terminal fragment of telopeptide of type I collagen in patients with renal osteodystrophy

BACKGROUND: Up until now, there was little known about the use of bone resorption markers in the assessment of bone status in patients with chronic renal failure (CRF). The present study evaluated the ability of a new immunoassay for N-terminal telopeptide of type I collagen to assess bone turnover in a group of hemodialyzed patients. METHODS: The following parameters were measured in a fasting blood sample from 111 patients on maintenance hemodialysis for at least 2 years and in 120 healthy subjects: calcium, phosphorus, magnesium, BALP, PTH, and N-terminal telopeptide of type I collagen (NTx-ELISA, OSTEOMARK NTx Siero-Ostex International). RESULTS: Serum PTH, BALP, and NTx were significantly higher (P<0.001) in hemodialyzed (HD) patients than in healthy subjects. In HD patients, PTH was correlated to BALP and NTx (r=0.40 and 0.55, respectively). When combining PTH and BALP serum levels, 17 patients showed high turnover (HT) and 65 were found to have a normal to low turnover (N-LT). In HT patients, serum NTx and dialytic age were significantly (P<0.01) higher than in N-LT patients. Moreover, even after adjusting for age, body mass index, dialytic age, and calcium-vitamin D treatment, serum NTx discriminated between HT and N-LT with a sensitivity of 97.6% and a specificity of 90.9%. CONCLUSION: Although bone biopsy remains the reference method for the diagnosis of renal osteodystrophy, the combined use of markers of bone resorption and bone formation could improve the clinical management of renal bone diseases.