National Bone Health Alliance Bone Turnover Marker Project: current practices and the need for US harmonization, standardization, and common reference ranges
- D. BauerAffiliated withUniversity of California Email author
- , J. KregeAffiliated withEli Lilly and Co., Inc.
- , N. LaneAffiliated withUniversity of California Davis Health System
- , E. LearyAffiliated withPacific Biomarkers
- , C. LibanatiAffiliated withAmgen
- , P. MillerAffiliated withColorado Center for Bone Research
- , G. MyersAffiliated withAmerican Association for Clinical Chemistry
- , S. SilvermanAffiliated withCedars-Sinai Medical Center
- , H. W. VesperAffiliated withCenters for Disease Control and Prevention
- and 3 more
- , D. LeeAffiliated withNational Bone Health Alliance
- , M. PayetteAffiliated withRoche Diagnostics
- , S. RandallAffiliated withNational Osteoporosis Foundation
- Show less
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This position paper reviews how the National Bone Health Alliance (NBHA) will execute a project to help assure health professionals of the clinical utility of bone turnover markers; the current clinical approaches concerning osteoporosis and the status and use of bone turnover markers in the USA; the rationale for focusing this effort around two specific bone turnover markers; the need to standardize bone marker sample collection procedures, reference ranges, and bone turnover marker assays in clinical laboratories; and the importance of harmonization for future research of bone turnover markers.
Osteoporosis is a major global health problem, with the prevalence and incidence of osteoporosis for at-risk populations estimated to be 44 million Americans. The potential of bone markers as an additional tool for health care professionals to improve patient outcomes and impact morbidity and mortality is crucial in providing better health care and addressing rising health care costs. This need to advance the field of bone turnover markers has been recognized by a number of organizations, including the International Osteoporosis Foundation (IOF), National Osteoporosis Foundation, International Federation of Clinical Chemistry, and Laboratory Medicine (IFCC), and the NBHA.
This position paper elucidates how this project will standardize bone turnover marker sample collection procedures in the USA, establish a USA reference range for one bone formation (serum procollagen type I N propeptide, s-PINP) and one bone resorption (serum C-terminal telopeptide of type I collagen, s-CTX) marker, and standardize bone turnover marker assays used in clinical laboratories. This effort will allow clinicians from the USA to have confidence in their use of bone turnover markers to help monitor osteoporosis treatment and assess future fracture risk. This project builds on the recommendations of the IOF/IFCC Bone Marker Standards Working Group by developing USA reference standards for s-PINP and s-CTX, the markers identified as most promising for use as reference markers.
The goals of this project will be realized through the NBHA and will include its governmental, academic, for-profit, and non-profit sector stakeholders as well as major academic and commercial laboratories. Upon completion, a parallel effort will be pursued to make bone turnover marker measurements reliable and accepted by all health care professionals for facilitating treatment decisions and ultimately be reimbursed by all health insurance payers.
Successful completion of this project will help assure health professionals from the USA of the clinical utility of bone turnover markers and ties in with the parallel effort of the IOF/IFCC to develop worldwide bone turnover reference ranges.
KeywordsBone turnover markers Position paper
- National Bone Health Alliance Bone Turnover Marker Project: current practices and the need for US harmonization, standardization, and common reference ranges
Volume 23, Issue 10 , pp 2425-2433
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- Bone turnover markers
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- Author Affiliations
- 1. University of California, San Francisco, USA
- 2. Eli Lilly and Co., Inc., Indianapolis, USA
- 3. University of California Davis Health System, Sacramento, USA
- 4. Pacific Biomarkers, Seattle, USA
- 5. Amgen, Thousand Oaks, USA
- 6. Colorado Center for Bone Research, Lakewood, USA
- 7. American Association for Clinical Chemistry, Washington, USA
- 8. Cedars-Sinai Medical Center, Los Angeles, USA
- 9. Centers for Disease Control and Prevention, Atlanta, USA
- 10. National Bone Health Alliance, Washington, USA
- 11. Roche Diagnostics, Indianapolis, USA
- 12. National Osteoporosis Foundation, Washington, USA