National Bone Health Alliance Announces Co-Chairs and Progress on its Bone Turnover Marker Standardization Project Efforts

WASHINGTON, Jan. 7, 2015 /PRNewswire-USNewswire/ -- The National Bone Health Alliance (NBHA) announced today that Robert Lindsay, MD, PhD and Paul Miller, MD, FACP are serving as co-chairs of its Bone Turnover Marker Standardization Project activities. Dr. Lindsay is the Chief of Internal Medicine, Helen Hayes Hospital and Professor of Clinical Medicine at Columbia University, New York, NY and Dr. Miller is the Medical Director at the Colorado Center for Bone Research in Lakewood, Colorado. As co-chairs of the project team, which includes members from academia, government agencies and the private sector, these internationally-recognized bone disease specialists will contribute their expertise to advance NBHA's effort to harmonize, standardize and identify common reference ranges for bone turnover markers.

Osteoporosis is a disease in which an individual's bones become thin and more likely to break. The disease is responsible for an estimated two million broken bones per year at a cost of $19 billion, a figure anticipated to rise to over $25 billion by the year 2025. Despite these statistics, nearly 80 percent of older Americans who suffer bone breaks are not tested or treated for osteoporosis. Medicare spends more than $5 billion annually to treat fractures among seniors and the majority of patients are released without being evaluated for osteoporosis – the underlying disease that likely led to the fracture. 

"Bone turnover markers are useful tools to identify patients at-risk for osteoporosis and can be used to monitor therapy, however short‐ and long‐term fluctuations related to biologic and technical variation have kept them from being widely used in clinical practice," said Dr. Lindsay.

"We're pleased to be working with a number of leading academic experts, the diagnostic and pharmaceutical industries, federal government representatives, as well as commercial and academic laboratories to improve the usefulness of these measurements," said Dr. Miller.

Under the leadership of Drs. Lindsay and Miller, the NBHA Bone Turnover Marker Standardization Project Team will implement a series of activities to harmonize and standardize the use of bone turnover markers. Following the recommendation of the project team's position paper published in Osteoporosis International in July 2012, the working group has started the Drug Holiday Study and the Common/Consistent Normative Reference Population Database Study, two of the five investigator-initiated studies called for by the 2012 bone turnover marker consortium.

Funded by Roche Diagnostics, the Drug Holiday Study aims to determine if biochemical markers will be effective in establishing the effect a drug holiday has on bone turnover for patients who have been on continuous bisphosphonate therapy for five years or more. Following concerns of adverse effects resulting after several years of continuous bisphosphonate treatment and the U.S. Food and Drug Administration's guidance that clinicians consider a holiday or break for patients after four to five years of continuous bisphosphonate use, this three-year study aims to provide clinicians with specific, evidence-based guidance on how to determine which patients should be considered for a drug holiday.

With funding by Amgen, Merck, Roche Diagnostics and Immunodiagnostic Systems, the Common/Consistent Normative Reference Population Database Study aims to define a common reference population database for a marker of bone formation (serum procollagen type I N propeptide, s-PINP) and a marker of bone resorption (serum C-terminal telopeptide of type I collagen, s-CTX) –  the two preferred bone turnover markers. In addition to the science provided by this research study, the data will allow comparisons of CTX/PINP results between the two immunoassay devices that provide multiple commercial laboratories with commercial testing. The data will help provide consistent results across the different types of machines used in practice and build greater trust in using biomarkers in clinical practice. NBHA will have ownership of the resulting database and will oversee its use for future research.

"Bone turnover markers have the potential to help identify people at risk for fracture," said David Lee, MPA, Executive Director, National Bone Health Alliance. "By eliminating the barriers to their use in clinical practice, our goal is to close the nearly 80 percent post-fracture care gap and ensure older adults with an increased risk for fracture are appropriately diagnosed and treated for osteoporosis."

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 to develop projects that can become reality through pooled funding. The 51 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.

CONTACT: David Lee, 202-721-6351, [email protected]

SOURCE National Bone Health Alliance

Related Links

http://nbha.org