Osteoporosis patients who take bisphosphonates, a widely prescribed class of drugs which is very effective in lowering bone fractures, may increase the risk ofatypical femur fractures - unusual but serious thigh bone fractures - if the medication is taken long term, a study revealed. The study, authored by a Task Force has been published in the medical journal Journal of Bone and Mineral Research.
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The authors stress that atypical femur fractures are very uncommon, and only represent approximately 1% of high and thigh fractures.
In response to growing concern about bisphosphonates and their link to unusual thigh bone (femur) fractures, the American Society of Bone and Mineral Research convened a task force. The U.S. FDA (Food and Drug Administration) said earlier on this year that it would wait for the report to come out before deciding on recommendations regarding bisphosphonates.
Task force co-chair and lead author Elizabeth Shane, M.D., of Columbia University, said, "For the vast majority of patients with osteoporosis, these drugs are an important weapon against fractures and their benefits far outweigh the risks of using them. Most of the patients who experienced these atypical femur fractures had been taking bisphosphonates for more than five years. However, we are concerned that there may be a relationship between these fractures and long-term bisphosphonate use and, although the risk is low, we want to make sure that people know about the warning signs."
The task force is calling for:
- Additional product labeling
- Improved identification and monitoring of patients who have these unusual thigh bone fractures
- More research into why and how bisphosphonates cause these uncommon bone fractures
The task force, consisting of experts from various countries and a variety of medical areas, carried out an extensive review of both published and unpublished data. They also interviewed researchers who work in companies that make and sell these drugs. They interviewed FDA staff - the FDA maintains a database that tracks reported side effects for approved drugs (MedWatch).
The researchers revealed that there appears to be a lack of awareness regarding atypical femur fractures, as well as their warning signs. Awareness also seems to be lacking regarding the link between bisphosphonates and thigh bone fractures.
At least half of all the patients with atypical femur fractures reported thigh or groin pain for weeks or months before the fractures occurred, the authors write. Over one quarter of those who fractured a thigh bone on one leg, went on to fracture the thigh bone on the other leg.
Bisphosphonates, which have been used by millions of osteoporosis patients, mostly women, were approved in 1995. They include the following brand names:
Osteoporosis, as well as other bone diseases, can have a drastic effect on a person's functions. Broken bones caused by osteoporosis can cause severe pain, loss of height, stooped posture, and breathing problems.
Approximately 20% of all patients who were able to walk before a hip fracture require long-term care afterwards. The rate of hip fractures is two to three times higher in women than in men. However, after one year, the death rate among males is almost twice as high as it is among females, the authors inform.
The task force recommends:
Shane said, "We know that bisphosphonates prevent many, many common fractures. For this reason, we want to emphasize that patients should not stop taking these drugs because they are afraid of the much more uncommon femur fractures. They should talk to their health professionals about their concerns and should let them know if they experience any new groin or thigh pain. Patients can also report any side effects of these medications to the FDA by phone or online.
- Product labeling should be altered so that doctors and patients are aware of the atypical femur fracture risk.
- All cases of thigh bone fractures that occur among patients taking bisphosphonates should be reported to the FDA MedWatrch program.
- New diagnostic and procedural codes should be developed for atypical femur fractures to improve the quality of case reporting and enable better review of medical records.
- In order to track cases of atypical femur fractures around the world, an international registry of patients who suffer such fractures should be established. This would also help future research.
Health professionals should reserve bisphosphonates for patients with certain cancers, Paget's disease of bone, and patients with osteoporosis who are at high risk of having a fracture. Drug labels should include information about this side effect. Although the risks are very low, health professionals should know the warning signs of atypical femur fractures and regularly ask patients on these drugs about groin or thigh pain. They also should assess annually whether this therapy is appropriate for each patient."
T.S. Wiley notes, "Osteoporosis affects women eight times more than men. One in two women over the age of fifty will suffer at least one lifetime fracture from osteoporosis. When we run out of estrogen and progesterone, our bones start to die very quickly. Bones have their own lifecycle or metabolism, a rhythm of growth or death governed by estrogen and progesterone. The fall off of estrogen in perimenopause means no peak of estrogen activity to make progesterone receptors which would build bone. This is the beginning of osteoporosis. Estrogen controls osteoclast activity. Ostoclasts are bone cells that eat up old bone for disposal. Progesterone controls osteoblastic activity. Osteoblasts are bone cells that build fresh new bone. Progesterone, in this case, grows bone, and estrogen takes it away so that new bone can grow again next month. Without this balanced interplay, one of two things can happen: Without estrogen, bones would overgrow into a cancer-like state, or without progesterone, unopposed estrogen would make bones brittle, fragile, thin and porous - osteoporotic.'
"So the treatment answer is simple. Natural, Biomimetic, transdermal, hormone replacement prescribed in a rhythm based normal cycle can do what no other treatments can do: revive your bones and furthermore the Wiley Protocol reverses bone loss after 18 months", states Wiley.
"Atypical subtrochanteric and diaphyseal femoral fractures: Report of a task force of the American Society for Bone and Mineral Research Authors"
Elizabeth Shane, David Burr, Peter R. Ebeling, Bo Abrahamsen, Robert A. Adler, Thomas D. Brown, Angela M. Cheung, Felicia Cosman, Jeffrey R. Curtis, Richard Dell, David Dempster, Thomas A. Einhorn, Harry K. Genant, Piet Geusens, Klaus Klaushofer, Kenneth Koval, Joseph M. Lane, Fergus McKiernan, Ross McKinney, Alvin Ng, Jeri Nieves, Regis O'Keefe, Socrates Papapoulos, Howe Tet Sen, Marjolein C.H. van der Meulen, Robert S. Weinstein, Michael Whyte
Journal of Bone and Mineral Research DOI:10.1002/jbmr.253
Medical News Today / T.S. Wiley