NEJM Published New Fosamax Study
The New England Journal of Medicine has recently published a study which showed that the safety in the long term use of bisphosphonate drugs, like Fosamax, for osteoporosis treatment may be in question. The showed that there have been two separate case series that suggest a further link between long term Fosamax use and atypical bone fractures. In one series, a small number of patients sustained low-energy non-vertebral fractures while receiving long-term alendronate therapy; three were fractures of the femoral shaft.
The study also showed that the bone biopsies in the patients showed evidence of severely suppressed bone turnover and fracture healing that was delayed or absent all together. Fosamax is actually suppress bone turnover and thus might be associated with accumulated micro-damage in bone in theory.
In the published study the editor states: “To our knowledge, no study has demonstrated microdamage accumulation in patients treated with bisphosphonates, and data from studies in animals remain difficult to interpret because supranormal doses of bisphosphonates are used. Nevertheless, the possibility that bisphosphonates alter bone strength with prolonged use appears to exist.”
The length of Fosamax use seems to be a factor that the study takes into account. The results of the study concluded that the patients who have been on Fosamax for an average time longer than five years were 37% more likely to suffer from atypical fractures than patients who have been on the drug for less time
Those who have already filed a Fosamax Lawsuit may take notice to the results of the study. As Merck and the FDA has both gone on record stating that more information is needed to link Fosamax to these types of bone fractures.
However the conclusion of the researchers have also stated that they need more information to definitely link Fosamax to atypical bone fractures. The editor concludes: “In light of the limitations of our study, a prospective study is indicated. Although many possible explanations exist, patients with the unique radiographic pattern shown here may represent a subgroup of the population that is more susceptible to the effects of prolonged suppression of bone turnover. Additional studies are needed to characterize this subgroup and to establish a clear association between atypical fractures of the femur and prolonged bisphosphonate treatment.”
URL References:
http://www.nejm.org/doi/full/10.1056/NEJMc0707493
http://health.usnews.com/usnews/health/healthday/080319/fosamax-linked-to-unusual-femur-fractures.htm
