Bone Turnover Marker Standardization Project

For several years, biochemical bone turnover markers (which help health care professionals assess changes in bone metabolism and determine the effectiveness of treatment) have been used in clinical trials as supportive data 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, which includes the participation of leading academic experts, the diagnostic and pharmaceutical industries, federal government representatives and a number of both commercial and academic laboratories.

Upon the conclusion of this project, an educational effort will be pursued to encourage clinicians to use these markers with confidence.