By Cindy Pearson
One after another, I watched the women come to the microphone. We had been sitting near each other all morning, waiting to speak at a Food and Drug Administration (FDA) meeting on osteoporosis. I went first, then sat down to watch the other speakers. Nearly a dozen women had come to tell their stories. Some were nervous. Others spoke confidently in front of the large crowd. They were from all around the country, and a variety of backgrounds. I listened carefully as they spoke, but I was also struck by what I was seeing.
The women were similar to one another in very striking ways: they were all older, energetic, vibrant, with great posture, nice clothes and attractive hairstyles. Sound familiar? It should. The women who gave their personal testimony looked a lot like the women featured in osteoporosis drug advertisements. But, unlike the women depicted in the ads, the women at the FDA meeting weren’t there to talk about how bisphosphonates helped them stay healthy. Instead, they told the FDA that bisphosphonates were hurting healthy women, and they used their own personal experience to make case for sweeping change in how bisphosphonates are used.
Most of the women who spoke at the FDA meeting had experienced a sudden and unprovoked broken leg. They talked about turning to put a piece of paper in the trash can, stepping away from the kitchen sink, or walking down the sidewalk — and suddenly collapsing in agonizing pain as their leg gave way. All of these women had been healthy and active before their leg broke. Some had been able to return to their normal activities after their leg healed; others had to endure multiple surgeries, delayed healing, and lingering worry that their next fracture might be just a step away. All of the women agreed that the way drug companies market and clinicians prescribe bisphosphonates is wrong and must be changed. These women echoed and reinforced NWHN’s position, which I presented at the meeting. We believe the FDA should limit bisphosphonate use to five years, and that clinicians should stop prescribing these drugs to healthy adults based solely on the result of a bone mineral density (BMD) test that finds osteopenia.
The NWHN will use all the advocacy tools at its disposal to press the FDA to make changes in how drug companies are allowed to market bisphosphonates like Fosamax, Actonel, Boniva and Reclast (as well as the many generic bisphosphonates) to healthy women. In the meantime, though, we want women and their clinicians to know what the data say about these drugs.
More isn’t better: Women who took a bisphosphonate for five years and then stopped had no fewer fractures than women who stayed on the drug for another five years. Five years seems to be the safest maximum time to take these drugs Some studies have reported an increased risk for these fractures after just four years.
Watch for warning signs of thigh fractures: At the meeting, women echoed the recommendations we’ve reported in the WHA, that anyone taking a bisphosphonate who experiences one-sided pain in the thigh or groin should have an X-ray to determine if a fracture is imminent. Surgery may still be required to strengthen the bone, but it’s much easier to fix a bone before it breaks completely.
Avoid oral surgery if you can: No one is exactly sure how often this happens, but the best estimate is that no more than 1 out of every 1,000 people taking bisphosphonates experiences jaw bone decay. An FDA-commissioned exploratory study about this found a four-fold increase in diagnosed cases of jaw bone decay among people who had taken bisphosphonates for over four years. It’s hard to know what to do to prevent this, other than taking care of your teeth and trying to avoid dental treatments from which your jaw might not heal well, such as oral surgery. Given how long bisphosphonates remain in the bone, it’s impossible to reduce the amount in your system by stopping the prescription shortly before oral surgery. So, it is very important to let your dentist know if you’re taking bisphosphonates.
Keep walking – but pay attention to your feet: Women speaking at the FDA meeting brought up another possible complication of bisphosphonates: broken bones in the feet. This complication hasn’t yet been reported in medical journals, but that lack of attention is about to change. With the help of Jennifer Schneider, a physician who herself has experienced an atypical femur fracture, women have collected over 100 accounts of bisphosphonate users who’ve had a femur fracture. Interestingly, 30% have also had a fracture of the long bones in their feet (metatarsals). This is a great example of community-led research that is designed and conducted by the affected individuals and that raises important issues to be explored more fully in the future. In the meantime, there aren’t any specific preventive measures a bisphosphonate user can take, and the women who spoke out at the hearing wouldn’t advise stopping exercise. But they do want others to know about their experience, and be aware of the possible association between the drug and broken foot bones.
Stay away from the bone mineral density scanner: Just say no! That’s our advice to almost all women under age 65, and maybe even many women 65 and older as well. WHA readers are familiar with NWHN’s critique of bone mineral density (BMD) screening. Unless you have a serious medical condition that creates fragile bones, or a very strong history of fragility fractures in your family, do not get a BMD test before you’re 65. If you’re White, you’re likely to be diagnosed with “osteopenia”, a condition that means nothing more than that your bones are less dense than the average 20-something’s. If you’re a woman of color, you’re likely to get a number that doesn’t tell you or your clinician anything at all, since women of color were left out of studies manufacturers used to define “normal” BMD. If you’re over 65, the age at which the U.S. Preventive Services Task Force recommends BMD screening, you can take stock of your own risk factors and make an informed decision.
Cynthia Pearson is the NWHN Executive Director
1. Park-Wyllie LY, et al. Bisphosphonate use and the risk of subtrochanteric or femoral shaft fractures in older women. JAMA. 2011 Feb23; 305(8):783-9.