Clinical Chemistry
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Clinical Chemistry 44: 2290-2300, 1998;
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(Clinical Chemistry. 1998;44:2290-2300.)
© 1998 American Association for Clinical Chemistry, Inc.


Enzymes and Protein Markers

Clinical evaluation of the Serum CrossLaps One Step ELISA, a new assay measuring the serum concentration of bone-derived degradation products of type I collagen C-telopeptides

Stephan Christgau1,a, Christian Rosenquist1, Peter Alexandersen2, Nina Hannover Bjarnason2, Pernille Ravn2, Christian Fledelius1, Christian Herling1, Per Qvist1, and Claus Christiansen2

1 Osteometer Biotech A/S, Osteopark, Herlev Hovedgade 207, 2730 Herlev, Denmark.

2 Center for Clinical and Basic Research, Ballerup Byvej 222, 2750 Ballerup, Denmark.
a Author for correspondence. Fax 45 4494 8940; e-mail Stephan_Christgau{at}osteobio.dk.

The Serum CrossLapsTM One Step ELISA is a sandwich assay using two monoclonal antibodies specific for a ß-aspartate form of the epitope EKAHDGGR derived from the carboxy-terminal telopeptide region of type I collagen {alpha}1-chain. Our objective was to assess the clinical value of the Serum CrossLaps assay for monitoring antiresorptive therapy in osteoporosis treatment. Samples obtained from postmenopausal women treated with different doses of cyclic or continuous hormone replacement therapy (HRT) with an estrogen analog (tibolone) or with a bisphosphonate (ibandronate) were measured in the Serum CrossLaps One Step ELISA at baseline and at various time points during therapy. The corresponding urine samples were measured in the urine CrossLapsTM ELISA and corrected for creatinine excretion. The serum CrossLaps measurements and corresponding urinary CrossLaps measurements were highly correlated (r >0.8 for all studies). The serum and urine CrossLaps measurements showed a significant decrease among the women treated with clinically relevant doses of either of the antiresorptive agents. Furthermore, the annual percentage change in bone mineral density (BMD) correlated with the measured changes in CrossLaps concentration. The serum CrossLaps assay showed a specificity of 83–100% and a sensitivity of 59–83% for assessing BMD changes. The corresponding values for the creatinine-corrected urinary measurements were 83–92% specificity and 68–79% sensitivity. We conclude that performance of the convenient Serum CrossLaps One Step ELISA is at least equivalent to that of the urine text for follow up of antiresorptive treatment in osteoporosis. Further studies are needed to optimize its use in this and other clinical applications.




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