Can Hip BMD substitute for fractures in clinical trials?

Clinical trials of new drugs for the prevention of fracture are extremely expensive and typically go on for at least 3 years. Investigators have tried for decades to find a new more efficient way of conducting these trials more efficiently. The Foundation for NIH project on Bone Quality at the SFCC has discovered that hip BMD is a good surrogate for hip fracture in clinical trials.

The project has compiled data from over 100,000 participants in over 40 clinical trials. They have pooled all of this data together to create the most powerful existing tool for studying ways to make clinical trials more efficient. The project compared changes in hip BMD during the course of these trials and the change in risk of hip fracture. The scientists discovered that every 1% improvement in hip BMD in the trials accurately predicted about a 5% decrease in the risk of hip fractures. This result was presented at a recent conference held by the FDA about new guidelines for clinical trials and has been submitted to FDA to consider revising their guidelines to accept BMD as a “surrogate” to allow clinical trials to use hip BMD as an endpoint for trials to approve drug therapies for prevention of fracture. This would be a revolutionary change in approval of new treatments for osteoporosis.