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ASBMR Task Force Report on Atypical Femoral Fractures Published in the JBMR
 
 
  Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Report of a Task Force of the American Society for Bone and Mineral Research: publication
 
Download the PDF here
 
Published on 09/14/10 by ASBMR
 
In a review published online in the Journal of Bone and Mineral Research (JBMR), an expert task force convened by the American Society of Bone and Mineral Research reports that bisphosphonates are highly effective in reducing common bone fractures in people with osteoporosis, but long term use of these medications may be related to unusual but serious fractures of the femur. In a review published online in the Journal of Bone and Mineral Research (JBMR), an expert task force convened by the American Society of Bone and Mineral Research reports that bisphosphonates are highly effective in reducing common bone fractures in people with osteoporosis, but long term use of these medications may be related to unusual but serious fractures of the femur. This expert panel reviewed 310 cases of "atypical femur fractures" and found that 94 percent (291) of patients had taken the drugs, most for more than five years. The task force members emphasized that atypical femur fractures represent less than one percent of hip and thigh fractures overall and therefore are very uncommon.
 
"For the vast majority of patients with osteoporosis, these drugs are an important weapon against fractures and their benefits far outweigh the risks of using them," said task force co-chair and lead author Elizabeth Shane, M.D., of Columbia University. "Most of the patients who experienced these atypical femur fractures had been taking bisphosphonates for more than five years. However, we are concerned that there may be a relationship between these fractures and long-term bisphosphonate use and, although the risk is low, we want to make sure that people know about the warning signs," she said.
 
The task force is calling for additional product labeling, better identification and tracking of patients experiencing these breaks, and more research to determine whether and how these drugs cause the serious but uncommon fractures. The task force report is available on the JBMR web site and the Wiley Online Library. JBMR has also issued a press release on the report, which may be viewed on here.
 
Reference
Shane, E., Burr, D., Ebeling, P. R., Abrahamsen, B., Adler, R. A., Brown, T. D., et al. Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: the FLEX trial. [published online ahead of print September 14, 2010]. J Bone Miner Res. DOI: 10.1002/jbmr.253
 
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Rare Fractures Tied to Bone Drugs
 
MedPage Today Staff Writer
Published: September 15, 2010
 
Action Points
 
· Explain to interested patients that a task force of the American Society of Bone and Mineral Research (ASBMR) is asking the FDA to change the labels of bisphosphonate drugs to include new information about an apparent increased risk of atypical femur fractures in a small number of patients.
 
A task force of the American Society of Bone and Mineral Research (ASBMR) is asking the FDA to change the labels of bisphosphonate drugs to include new information about an apparent increased risk of atypical femur fractures in a small number of patients.
 
The task force made the recommendation for a label change based on its review of 310 cases of atypical femur fractures. That review, published in the Sept. 14 issue of the Journal of Bone and Mineral Research, found that 94% of patients (291) who had experienced such fractures were taking bisphosphonates for more than five years.
 
But the task force also cautioned that atypical femur fractures are rare -- 1% of hip and thigh fractures overall.
 
"For the vast majority of patients with osteoporosis, these drugs are an important weapon against fractures, and their benefits far outweigh the risks of using them," said lead author and task force co-chair Elizabeth Shane, MD, of Columbia University in New York City, in a press release. Shane added "we are concerned that there may be a relationship between these fractures and long-term bisphosphonate use and, although the risk is low, we want to make sure that people know about the warning signs."
 
Since they were approved in 1995, millions of people -- mainly women -- have been treated with bisphosphonates and their derivatives, including alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel) and zoledronic acid (Zometa), which prevent bone remodel ing and resorption.
 
According to some animal and preclinical data cited in the report, one possible mechanism for the atypical femur fractures may be that the reduction in bone remodeling due to bisphosphonates is "also associated with increased micro-damage accumulation because cracks are not efficiently removed." Shane and co-authors added that "the evidence also suggests that decreased remodeling is not solely responsible for reduced [bone] toughness, implicating a specific effect of BPs that is independent of reduced turnover."
 
In March, the FDA said it was waiting for the ASBMR report before making new labeling recommendations. However, at that time the agency notified healthcare professionals and patients that the data so far had not shown a clear connection between bisphosphonate use and the risk of atypical femur fractures.
 
That same month, researchers at the University of California San Francisco reported in a meta-analysis of studies including more than 14,000 patients that atypical femoral fractures in patients with osteoporosis were extremely rare -- and not significantly more common with bisphosphonates.
 
As a result of its current review, the ASBMR task force called for additional product labeling, better identification, and tracking of patients experiencing these breaks. The task force also urged more research to determine whether and how bisphosphonates cause the serious but uncommon fractures.
 
Although many people who experience atypical femur fractures have no warning signs, the task force noted that more than half of the patients had reported groin or thigh pain for weeks or months before the fractures actually occurred, and more than a quarter of those who experienced atypical femur fractures in one leg suffered a fracture in the other leg as well.
 
In its statement, the ASBMR task force recommended:
 
· Product labeling should be changed to alert health professionals and patients to the possibility of atypical femur fractures for patients on bisphosphonate therapy and the associated warning signs.
 
· New diagnostic and procedural codes should be developed for atypical femur fractures to improve the quality of case reporting and enable better review of medical records.
 
· An international registry of patients experiencing aty pical femur fractures should be established to track cases and facilitate future research.
 
"We know that bisphosphonates prevent many, many common fractures. For this reason, we want to emphasize that patients should not stop taking these drugs because they are afraid of the much more uncommon femur fractures. They should talk to their health professionals about their concerns and should let them know if they experience any new groin or thigh pain. Patients can also report any side effects of these medications to the FDA by phone or online," Shane said in the press release.
 
Shane added that health professionals "should reserve bisphosphonates for patients with certain cancers, Paget's disease of bone, and patients with osteoporosis who are at high risk of havi ng a fracture."
 
She also supported the idea that drug labeling should include information about femur fracture risk and its warning signs.
 
Shane disclosed financial relationships with Merck, Novartis, Eli Lilly, makers of some bisphosphonate drugs, along with the editorial board of the journal B one.
 
Other study co-authors also disclosed financial relationships with these and other pharmaceutical companies.
 
Primary source: Journal of Bone and Mineral Research
Source reference:
 
Shane E et al "Atypical subtrochanteric and diaphyseal femoral fractures: Report of a task force of the American society for bone and mineral research" (Running Title: "Atypical femoral fractures task force report") J Bone Miner Res 2010; Published online Sept. 14, 2010.
 
 
 
 
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