At EmpowHer, we have a thread where women have reported femur fractures while using the drug Fosamax, a medicine meant to help build bones for those suffering from osteoporosis. It turns out these women aren't alone.

There have even been a couple of research studies showing the link.

On Wednesday, the Food and Drug Administration said it is doing a safety review of the drugs known as bisphosphonates, which include Fosamax, Boniva and Actonel, specifically to see if there’s a risk of fractures to the femur just below the hip joint in patients who have taken the drugs for several years. However, the agency says that the information they have so far reviewed has not shown a clear connection between the drugs and the fractures. From the Wall Street Journal:

“Two studies presented Wednesday at the American Academy of Orthopaedic Surgeons' annual meeting suggest the drugs might adversely affect bone quality and increase risk of atypical fractures of the femur, or the main bone in the thigh, when used for four or more years.

“The FDA said it had requested information from drug manufacturers in 2008 after seeing case reports about femur fractures occurring in women with osteoporosis using bisphosphonates.

"FDA's review of these data did not show an increase in this risk in women using
these medications," the agency said in a statement posted to its Web site Wednesday. The agency also cited a 2008 study that found similar femur fracture rates among women taking bisphosphonates compared to women not taking the drugs. The study found that the femur fractures had many features in common with osteoporotic hip fractures.”

What does that mean? Simply put, the FDA can’t be sure whether the fractures have to do with the osteoporosis or the medicines meant to prevent it.

There does seem to be a correlation between the length of time patients have taken the drugs and the increased risk. The studies showed that the bones of some women stop rejuvenating after five or so years on the drug and become brittle.

"That's the paradox," Melvin Rosenwasser, chief of orthopedic trauma surgery at Columbia University Medical Center in New York, told USA Today. "These drugs are good drugs. They strengthen bone and protect you from fractures for a while. But in some people they can become deleterious after a period of time." More from that report:

“The drugs are effective initially in slowing bone loss, says Joseph Lane, chief of metabolic bone disease service at the Hospital for Special Surgery in New York. Research he will present today at the annual conference of American Academy of Orthopedic Surgeons in New Orleans was designed to explore why one in 50 women who got fractures and were on the drugs for more than five years suffered atypical hip fractures of the femur.

"These are healthy active women, not women in nursing homes," Lane says. "Hip fractures can be life-threatening, so we want to find out what's causing them in thriving women."

“Studying bone biopsies in women who suffered femur fractures, Lane found the quality of the bone diminished after long-term bisphosphonate use.

"Normally bone is a distribution of young bone, middle-age bone and old bone," he says. "When we look at these bones, it's old bone. You begin to start having imperfections in the bone. It's not as good as younger bone."

An estimated 10 million Americans have osteoporosis, and 34 million have low bone mass, putting them at risk. The National Osteoporosis Foundation has a page on its website titled “Special Concerns About Biophosphates,” good reading for anyone concerned about these and previous studies.

Here’s a link to that page:
http://www.nof.org/news/pressreleases/F-1_Special_Concerns_About_Bisphos_2009.pdf

And here’s the original EmpowHer thread:
https://www.empowher.com/community/share/fosamax-and-femur-fractures

The Wall Street Journal story:
http://online.wsj.com/article/SB10001424052748703976804575114181349999398.html

The USA Today story:
http://www.usatoday.com/news/health/2010-03-11-bones11_st_N.htm