The Foundation for NIH (FNIH) Biomarkers Consortium has just launched a three year study called the “FNIH Biomarkers Consortium Bone Quality Project” to track the progression of osteoporosis more precisely and pave the way for more effective treatments. The study which uses data from existing academic and clinical trials will be able to establish specific imaging and biochemical markers for bone health.
Over the last twenty years, progress has been made in both the diagnosis and treatment of osteoporosis. However, substantial challenges remain that include limited treatment efficacy for non-spine fractures, limited evidence that anti-osteoporosis drugs prevent fractures with individuals that do not yet have osteoporosis, plus there is a lack of data to support the efficacy of a given treatment beyond the duration of most clinical trials.
Recent concerns have prompted regulatory agencies to review the safety of antiresorptive drugs taken for osteoporosis. This is causing concern among patients and physicians and as a result, the use of these drugs are decreasing.
The Bone Quality Project will evaluate the effectiveness of two types of biomarkers to measure bone strength to include Quantitative Computed Tomography (QCT), a state-of-the-art imaging technology and Biochemical Markers of bone turnover (BTM) defined as biomarkers of bone formation.
Both QCT and BTM were included in existing clinical trials in small subsets of patients with some relevant analyses previously performed. However, analytic methods have varied greatly among the existing analyses and small sample sizes which limited drawing definite conclusions about their utility.
“The Bone Quality Project will take advantage of the many thousands of patients who have already been studied over the years in both academic and industry settings by pooling the data from the QCT and BTM sub-studies to conclusively establish the value of these measurements for drug development and clinical use,” said Dr. Dennis Black, the Principal Investigator from the University of California, San Francisco.
Financial support is being provided through funds contributed from the American Society for Bone and Mineral Research, Amgen, Inc., Eli Lilly and Company, Merck & Co, and the Dairy Research Institute.
For more information, go to www.fnih.org.