Osteoporosis and other bone diseases are identified as the emerging medical conditions for attention during the 21st century. Bone mineral density (BMD) is considered the gold standard of bone status assessment in osteoporosis and related diseases; however, BMD does not offer the timely response desirable for monitoring therapeutic response. Serum biochemical markers (SBMs) of bone metabolism offer the potential for screening of individuals for bone turnover conditions and for monitoring of early response to therapy. Roche Diagnostics provides 3 SBMs on fully automated Elecsys® electro-chemiluminescent immunoassay analyzers: beta-CrossLaps (CTx, resorption biomarker), N-MID Osteocalcin (OC, formation biomarker) and N-terminal propeptide of procollagen type I (P1NP, formation biomarker). Three laboratories participated in evaluation of the Roche SBMs on 3 Elecsys platforms: E1010, E2010 and E170. Human serum samples were collected under IRB approved informed consents with confidentiality ensured through de-identification of the donors in the laboratories and in the database.
Total imprecision in human serum pools on the 3 Elecsys platforms over 10 runs was within the manufacturer's specifications of less than 7% at the diagnostic decision levels for the 3 SBMs
Over 900 medically characterized healthy and osteoporotic donors were drawn in the U.S. and serum samples were assayed on the E2010. Reference interval levels for all 3 SBMs demonstrate statistically different median levels between premenopausal and post-menopausal women (with and without osteoporosis)and healthy men. Racial differences between healthy Caucasians and African Americans in the SBMs were found. Reference intervals for the U.S. population indicate the potential utility of the 3 SBMs for screening individuals for bone metabolism conditions.
A mean decrease of 37% in CTx was observed by 4 weeks and approximately 20% in OC and P1NP by 12 weeks following an anti-resorptive therapy in post-menopausal, osteoporotic women. These changes demonstrate the clinical utility of Roche Diagnostics CTx, OC and P1NP in early monitoring of therapeutic response. Non-responders were also clearly identified early in the therapeutic course.
Disclosure Information:
Faculty Member's Name: Ann P. Foster, CCRA
Other Financial or Material Support: I am an employee of Roche Diagnostics.
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