NBHA Bone Turnover Standardization Marker Project publishes position paper

Washington, DC, July 14, 2012 – National Bone Health Alliance Bone Turnover Standardization Marker Project: current practices and the need for US harmonization, standardization, and common reference ranges position paper published in Osteoporosis International (July 2012)

For several years, biochemical markers have been used in clinical trials as supportive data for the effects of drugs and have been recognized as potentially useful tools in clinical practice - however, some shortcomings have minimized their use, including considerable short- and long-term fluctuations and technical variability (both within laboratory and between laboratory sample collection and analysis).

To address these issues, NBHA is executing a project that builds on the recommendations of the International Osteoporosis Foundation (IOF)-International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Bone Marker Standards Working Group position paper regarding the use and utility of bone turnover markers in clinical practice, which:

• reviewed the literature to determine the clinical potential of bone turnover markers;
• identified one bone resorption marker (serum C-terminal telopeptide of type I collagen, s-CTX) and one bone formation marker (serum procollagen type 1 N propeptide, s-P1NP) as most applicable as reference markers; and
• recommended, as an interim solution, a strategy of harmonization of assays involving comparison studies between different routine clinical assays.

The NBHA project team published a position paper in July 2012 in Osteoporosis International that elucidates the current challenges regarding the widespread use of bone turnover markers and describes the elements of the NBHA project that will be executed over the next year:

• determining the degree of variation between manufacturer assays;
• reducing the biological variability in the collection of serum (to analyze the s-P1NP and s-CTX bone turnover markers);
• reducing within/between laboratory variation in sample collection/analysis; and
• establishing standardized protocols that the various laboratory vendors can agree on that would provide confidence to clinicians utilizing these tests.

The authors of the NBHA position paper include Douglas Bauer, MD, University of California San Francisco; Nancy Lane, PhD, University of California Davis; Elizabeth Leary, PhD, Pacific Biomarkers; John Krege, MD, Eli Lilly and Company, Inc.; Cesar Libanati, MD, Amgen; Paul Miller, MD, University of Colorado Health Sciences Center; Gary Myers, PhD, American Association for Clinical Chemistry; Michelle Payette, MD, Roche Diagnostics; Stuart Silverman, MD, Cedars-Sinai/University of California, Los Angeles; Hubert Vesper, PhD, Centers for Disease Control and Prevention; David Lee, National Bone Health Alliance; and Susan Randall, National Osteoporosis Foundation.

For more information or to schedule an interview with an NBHA expert, please contact Valerie Patmintra at (202) 320-6388 or valerie.patmintra@nbha.org.

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About the National Bone Health Alliance

Established in late 2010, the National Bone Health Alliance is a public-private partnership that brings together the expertise and resources of various partners across a broad spectrum to promote bone health and prevent disease; improve diagnosis and treatment of bone disease; and enhance bone research, surveillance and evaluation. The NBHA is a platform that allows all voices in the bone health community to work together around shared priorities and develop projects that can become reality through pooled funding. The 46 members of the Alliance (in addition to liaisons representing the Centers for Disease Control and Prevention, National Aeronautics and Space Administration, National Institutes of Health and U.S. Food and Drug Administration) are working from a shared vision: to improve the overall health and quality of life of all Americans by enhancing their bone health. For more information on the NBHA, visit www.nbha.org.