International Osteoporosis Foundation: No Automatic Drug “Holiday!”

The International Osteoporosis Foundation (IOF) Working Group has just released a new editorial urging physicians to individualize treatment based on patients’ fracture risk, as opposed to automatically interrupting or stopping bisphosphonate therapy after five or three years.

As indicated in the January 4, 2016 news release, “The concept of a bisphosphonate ‘holiday’ arose following concerns about osteonecrosis of the jaw (ONJ) and atypical femoral fracture (AFF), rare events which have recently been linked to long-term use of bisphosphonates.”

Lead author Professor Stuart Silverman, M.D., Cedars-Sinai Medical Center and Professor of Medicine, University of California, Los Angeles (UCLA) noted in the news release, “…In the meantime we want to remind physicians and patients alike that while the incidence of AFF and ONJ are very rare, hip and spinal fractures in high risk patients are, in contrast, far more common and a major cause of disability, loss of quality of life and early death. The benefits of bisphosphonate therapy with regard to reduced fracture incidence in moderate and high risk women clearly outweigh the risk of rare adverse events.”

Professor Silverman told OTW, “The editorial began as a response to what I was seeing in my own practice as a rheumatologist and osteoporosis clinician and what other members of the IOF working group were also seeing in their practices. We were seeing patients who were at high risk of further fracture (based on bone density or history of fracture) who had been on oral bisphosphonate therapy for three to five years and who had stopped their medication and were now on bisphosphonate holiday. Some of these patients were being placed on bisphosphonate holiday by their doctors but others stopped the medication on their own without consulting a doctor due to media coverage of side effects such as osteonecrosis of the jaw (ONJ) or atypical femoral fracture. These side effects are rare in comparison to the benefits of reducing fracture risk and fracture complications. The physicians and patients were not considering their fracture risk when stopping the medication and their need for continued therapy.”

“When clinicians began to see patients on bisphosphonate holiday who then began to fracture after several years off therapies, we became even more concerned. Then, when we began to see patients who were at high risk of fracture who refused osteoporosis medications, not only bisphosphonates, because they perceived the medications as dangerous, we realized that the concerns about bisphosphonates being picked up by the media were frightening patients to stop their therapies on their own or to not take them at all. The patients were not understanding that the risks are very small in comparison to the large benefits of risk reduction of fracture. As we know, fractures are associated with considerable morbidity and mortality.”

“To address these concerns, a proposal was made to the IOF working group to do an international survey of the current clinical management of bisphosphonate holidays. The results of the survey showed that the members of the IOF working group did agree that patients at high risk needed to continue therapy, although there was disagreement on the exact definition of high risk. The IOF working group then chose to use the results of the survey to develop an editorial to address the need to continue to treat patients with osteoporosis at high risk of fracture.”