Osteoporosis is the most common type of bone disease, but this week in an attempt to fight back against the sickness a hearing will be held by the U.S. Food and Drug Administration (FDA) to examine the benefits and risks of a widely prescribed treatment for osteoporosis, the long-term use of bisphosphonates. Dr. Elizabeth Shane, one of the nation’s leading experts on osteoporosis treatment will lead the analysis.
Dr. Shane is past-president of the American Society for Bone and Mineral Research (ASBMR) and an endocrinologist and professor of Medicine at Columbia University in New York, with more than 25 years of experience caring for patients with osteoporosis. Additionally she served as co-chair of two ASBMR scientific task forces on bisphosphonate use.
Osteoporosis, one of the most devastating chronic diseases of aging, currently affects more than 10 million Americans. Another 34 million women and men have low bone mass, which may progress to osteoporosis. In all, osteoporosis costs $19 billion annually in hospitalizations, treatment and emergency room visits for fractures, which are the main symptoms of osteoporosis.
Without treatment, one in two women and one in four men age 50 and above will experience a fracture due to osteoporosis. Among seniors with osteoporosis, one in five who break a hip will die within a year from complications related to the break. With the aging of the American population, these numbers are expected to increase exponentially over the next 20 years and beyond.
The leading causes of osteoporosis are a drop in estrogen in women at the time of menopause and a drop in testosterone in men. Women over age 50 and men over age 70 have a higher risk for osteoporosis.
Bisphosphonates are antiresorptive medicines, which means they slow or stop the natural process that dissolves bone tissue, resulting in maintained or increased bone density and strength. This may prevent the development of osteoporosis. If osteoporosis has already developed, slowing the rate of bone thinning reduces the risk of broken bones.
The FDA is convening the advisory panels for a closer look at safety of the long-term use of bisphosphonates, given concerns about the rare but serious side effects of osteonecrosis of the jaw (bone disease of the jaw or ONJ) and atypical femur fractures (unusual thigh bone breaks).
In the pre-meeting notes, it states that Dr. Shane will testify that bisphosphonates are very important drugs for prevention of fractures due to osteoporosis. While bisphosphonates are associated with ONJ and atypical femur fractures, the absolute risk of both conditions is very low, particularly when compared to the number of extremely common fractures prevented by these drugs.
For patients at high risk of having an osteoporotic fracture, and for those with Paget’s Disease and certain forms of cancer, the benefits of bisphosphonates outweigh the risks of taking them. Twenty years ago, physicians had very few treatment options for osteoporosis. Today, many high quality clinical trials have established that bisphosphonates prevent most types of serious fractures and thus are of benefit to millions of patients in the U.S. and worldwide.
Shane will also push for new diagnostic and procedural codes should be developed for atypical femur fractures, as has already been accomplished for ONJ, to improve the quality of case reporting and enable better review of medical records.
Also to be recommended is an international registry of patients experiencing atypical femur fractures should be established to track cases and facilitate future research.
Written by Sy Kraft