“Every drug has side effects,” Dr. Shane said in an interview. “It may well be that this type of fracture is associated with bisphosphonates, but we don't yet know who is vulnerable and we need more information and more research in order to determine that.”
One goal of the task force convened by the American Society of Bone and Mineral Research will be to guide future research. The group, which began meeting last year, also is working to establish a case definition, review the literature, compare imaging techniques, and consider the best management of patients with these fractures.
The task force expects to wrap up its work in the next few months, Dr. Shane said. Once completed, a report will be submitted to the Journal of Bone and Mineral Research and to the FDA. The task force is likely to recommend establishment of an international registry, allowing researchers to better study the rare fractures, she said.
The FDA statement is at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm
“We don't yet know who is vulnerable” to rare instances of atypical subtrochanteric fracture, Dr. Elizabeth Shane said.
Source: Courtesy Columbia University Medical Center
A typical osteoporosis fracture (left), is contrasted with an atypical fracture in a patient after many years of bisphosphonate therapy.
Source Images courtesy Dr. Melvin Rosenwasser, Columbia University
My Take
Risk, Benefit Merit Discussion With Patients
Shortly after these two small case studies were presented at the American Academy of Orthopedic Surgeons meeting, ABC World News Tonight reported on the potential hazards of prolonged bisphosphonate therapy. Three days later, these studies appeared on the front page of USA Today. The reporting included some dramatic images of proximal femoral fractures, and newcaster Diane Sawyer highlighted the extensive prescribing of oral bisphosphonates by primary care physicians. She even wondered whether they (we) had any knowledge of these problems.
Although the findings were newsworthy, the two studies found nothing conclusive as to the effects of long-term use of antiresorptive therapy and these unique fractures. Moreover, the FDA has no plans to change its recommendations regarding drug labeling of oral bisphosphonates in light of these reports. It may be all noise with no signal, but there are plans to further investigate the issue.
To return to Ms. Sawyer's musings, as a primary care physician I have long questioned the use of oral bisphosphonates beyond the 5-year mark, and many of my colleagues are in the same camp. The data beyond 5 years do support continuing use, but are not as robust as for the first 5 years of therapy. We all know that bisphosphonates make for denser bones; the question raised once again is all about bone quality.
Physicians who prescribe oral bisphosphonates should talk about risk versus benefit with these patients. They should address these questions not only in the first year, but also in the 5th year and 10th year, should these drugs be used for that length of time.