This year’s Rheumatology Research Foundation Oscar S. Gluck, MD, Memorial Lecture made the case that there is a crisis in the treatment of osteoporosis.
“A big part of the crisis has to do with how we use bisphosphonates safely and effectively,” said Kenneth G. Saag, MD, MSc, the Jane Knight Lowe Professor and Vice Chair of Medicine and Director of the Center for Outcomes, Effectiveness Research, and Education at the University of Alabama at Birmingham. “We don’t really know all we need to know about bisphosphonates, such as their long-term safety and efficacy and whether to give patients a holiday from the drugs.”
The crisis concerns patients’ fears of rare side effects of bisphosphonates. According to an article in the New York Times, researchers contend that millions of Americans are missing out on a chance to avoid debilitating fractures from weakened bones because they are terrified of exceedingly rare side effects from bisphosphonates.
According to an article in the Journal of Bone and Mineral Research, the remarkable progress made over the past 30 years to reduce fractures and dramatically improve the quality of life for millions of osteoporosis patients is rapidly being reversed, Dr. Saag said.
Too many patients at high risk for fractures are not being diagnosed or treated to prevent them. Evidence shows that high-risk patients are not getting appropriate therapy despite research showing the effectiveness of several osteoporosis drugs in preventing fractures.
About 250,000 bone fractures occur every year in the United States, and more than 65,000 American women die from complications of hip fractures each year. Fifty percent of hip fracture survivors are permanently incapacitated, and 20 percent of them require long-term nursing-home care, yet bisphosphonate use is declining in the United States, he said.
“The bisphosphonates are the most commonly used drugs to treat fractures. They go into, live in, and build up in bone. If you stop the bisphosphonate, there will be an exponential loss over time,” he said.
The FLEX (Fracture Intervention Trial Long-Term Extension) study found that among postmenopausal women who discontinued alendronate therapy after four to five years, older age and lower bone mineral density in the hip at discontinuation predicted clinical fractures during the subsequent five years.
Among the adverse effects of long-term bisphosphonate use is that atypical stress fractures increase with the number of years bisphosphonates are used.
According to FDA regulatory guidelines, the optimal duration of bisphosphonate use has not been determined. For patients at low risk for fractures, physicians should consider drug discontinuation after three to five years of use, Dr. Saag said.