Biphosphonates and Bone Health
A New Concern: Atypical fractures and bisphosphonates
Atypical fractures of long bones have been reported in 310 patients, most but not all of which have been associated with bisphosphonate treatments. The American Society for Bone and Mineral Research (ASBMR) have reviewed reports and preclinical studies and have now defined atypical fractures and have recommended a change in labeling for bisphosphonates, including the establishment of an international registry to facilitate clinical and genetic risk factors as well as optimal fracture management.[1] The FDA has recently announced that warnings and precautions regarding atypical fractures of the thigh should now be on the drugs’ labels as well as an admission that optimal duration of use has not yet been determined. Only the drugs used to treat osteoporosis (not Paget’s disease or cancer-related hypercalcemia) are affected. These include Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast and their generics.
Fewer than 1% of all hip and femur fractures are now these atypical fractures, which may be related to long-term bisphosphonate use. Research is currently underway that in the next 2 to 3 years will likely identify small subsets of patients with metabolic or genetic disorders that make them susceptible to these atypical fractures, especially in those women on bisphosphonates. Until this information is forthcoming, Dr. Michael McClung, the Director of the Oregon Osteoporosis Center in Portland, Oregon and an advisor to the North American Menopause Society asks clinicians to consider the following clinical recommendations: (source: North American Menopause Society: First to Know December 28, 2010. Atypical fracture and bisphosphonates. Michael McClung, M.D.
- Restrict the long-term (> 3 years) use of potent antiresorptive agents to patients with osteoporosis or high fracture risk, and avoid their use in patients with low bone mass (osteopenia) without other risk factors who are at low risk of fracture.
- Do not combine bisphosphantes or denosumab with estrogens or estrogen agonist/antagonisits (known as SERMs) without documentation of inadequate response to estrogen or estrogen or estrogen agonist/antagonists.
- For individuals who are candidates for bisphosphonate therapy and meet the current guidelines for treatment indications, the risk of hip or spine fracture is much greater without treatment than the risk of having an atypical fracture on treatment, especially during the first 5 years.
- Individuals who are at high risk for fractures due to osteoporosis should not discontinue their bisphosphonate therapy on the basis of fears of atypical fractures.
- Individuals should be reevaluated annually to determine the justification for bisphosphonate therapy. Encourage patients to report any thigh pain immediately so that proper evaluation and management takes place prior to any frank femoral fracture.
[1] Shane E, Burr D, Ebeling P, et al. For the American Society for Bone and Mineral Research. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2010;25:2267-2294.
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-LRR
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