Sept. 9 Hearing to Examine Benefits, Risks of Long-Term Bisphosphonate Use
WASHINGTON – Dr. Elizabeth Shane, one of the nation’s leading experts on osteoporosis treatment, will provide expert testimony on Friday, September 9 at a joint hearing of two U.S. Food and Drug Administration (FDA) advisory committees that are examining the benefits and risks of a widely prescribed treatment for osteoporosis. The FDA is convening the advisory panels for a closer look at safety of the long-term use of bisphosphonates, given concerns about the rare but serious side effects of osteonecrosis of the jaw (bone disease of the jaw) and atypical femur fractures (unusual thigh bone breaks).
Dr. Shane is past-president of the American Society for Bone and Mineral Research (ASBMR) and an endocrinologist and professor of Medicine at Columbia University in New York, with more than 25 years of experience caring for patients with osteoporosis. Additionally she served as co-chair of two ASBMR scientific task forces on bisphosphonate use. ASBMR convened the task force on osteonecrosis of the jaw (ONJ) in 2007 and a second task force on atypical femur fractures in 2010, in the wake of concerning reports of these conditions in patients using bisphosphonates. Each task force reviewed all published cases and unpublished data on both issues; both task force reports are among the most comprehensive scientific reports to date on these topics. Both task force reports, as well as a statement that Dr. Shane provided to the FDA on behalf of ASBMR in advance of the hearing is available below.
Summary of Task Force Findings and Recommendations
Based on the two task force reports, as well as literature published after the reports, Dr. Shane will testify that bisphosphonates are very important drugs for prevention of fractures due to osteoporosis. While bisphosphonates are associated with ONJ and atypical femur fractures, the absolute risk of both conditions is very low, particularly when compared to the number of extremely common fractures prevented by these drugs. For patients at high risk of having an osteoporotic fracture, and for those with Paget’s Disease and certain forms of cancer, the benefits of bisphosphonates outweigh the risks of taking them. Twenty years ago, physicians had very few treatment options for osteoporosis. Today, many high quality clinical trials have established that bisphosphonates prevent most types of serious fractures and thus are of benefit to millions of patients in the U.S. and worldwide.
Following publication of the atypical femur fracture report, the FDA revised its product labeling to provide more information about potential side effects. The ASBMR task force commends this change and believes it will help ensure that patients and physicians better understand the risks and warning signs. Additional recommendations from both task forces include:
- New diagnostic and procedural codes should be developed for atypical femur fractures, as has already been accomplished for ONJ, to improve the quality of case reporting and enable better review of medical records.
- An international registry of patients experiencing atypical femur fractures should be established to track cases and facilitate future research.
- Patients who are taking bisphosphonates for osteoporosis or cancer should not stop taking these medications, because they prevent many common fractures. They should talk to their health professionals about any concerns and also let them know if they experience any new groin or thigh pain.
- Health professionals should prescribe appropriate medication, including bisphosphonates, for those patients with osteoporosis, including both those at high risk of having a fracture and those who have already fractured. They should also be educated to know the warning signs of ONJ and atypical femur fractures and assess each patient regularly to determine whether the continuation of therapy is appropriate for each patient.
Osteoporosis, one of the most devastating chronic diseases of aging, currently affects more than 10 million Americans. Another 34 million women and men have low bone mass, which may progress to osteoporosis. In all, osteoporosis costs $19 billion annually in hospitalizations, treatment and emergency room visits for fractures, which are the main symptom of osteoporosis. Without treatment, one in two women and one in four men age 50 and above will experience a fracture due to osteoporosis. Among seniors with osteoporosis, one in five who break a hip will die within a year from complications related to the break. With the aging of the American population, these numbers are expected to increase exponentially over the next 20 years and beyond.
For more information or to schedule an interview with Dr. Shane, please contact Doug Fesler at firstname.lastname@example.org or (202) 367-1161 or Sara Knoll at email@example.com or (301) 652-1558.
ASBMR Report on Atypical Femur Fractures
ASBMR Report on Osteonecrosis of the Jaw
ASBMR Submitted Written Testimony to FDA