A University of British Columbia and Vancouver Coastal
Health Research Institute study has found that a popular
class of osteoporosis drugs nearly triples the risk of
developing bone necrosis, a condition that can lead to
disfigurement and incapacitating pain.
The research is the largest study of bone necrosis and
bisphosphonates, a class of drugs used by millions of
women worldwide to help prevent bone fractures due to
osteoporosis. It is also the first study to explore the
link between bone necrosis and specific brands of bisphosphonates,
such as Actonel, Didrocal and Fosamax. Researchers found
that all three brands had similar outcomes.
Bone necrosis, a relatively rare disease diagnosed in
approximately 1 in 20,000 people per year, leads to permanent
loss of blood supply to the bones. Without adequate blood
supply, the bone tissue dies and causes the bone to collapse.
The disease primarily affects shoulders, knees and hips
at the joints, causing severe pain and immobility.
Published online by the Journal of Rheumatology today,
the findings follow a recent U.S. Food and Drug Administration
alert about bisphosphonates that highlighted the possibility
of severe and sometimes incapacitating bone, joint and/or
muscle pain in patients taking the drugs.
According to the American Dental Association, more than
190 million prescriptions have been written for bisphosphonates
worldwide. The drugs are promoted in direct-to-consumer
advertisements on U.S. television stations.
“The message for women taking these medications is to
pay attention to your pain,” said principal investigator
Dr. Mahyar Etminan of the Centre for Clinical Epidemiology
and Evaluation at UBC and VCHRI. “Given the widespread
use of these drugs, it is important that women and their
doctors know the risks that come with taking them.”
Etminan cautions that bisphosphonate use may increase
in the future as the possible link between estrogen use
and breast cancer prompts women to switch from estrogen
therapy to bisphosphonate therapy to prevent osteoporotic
bone fractures. Another reason may be the availability
of new bisphosphonates that come in once-a-month or once-a-year
doses.
The epidemiological study, a collaboration between UBC,
VCHRI and McGill University, is based on the health records
of 88,000 Quebec residents from 1996 to 2003. The team
undertook the research after academic papers began linking
necrosis of the jaw with the use of bisphosphonates.
“This is particularly important work,” said Dr. John
Esdaile, professor and head, Rheumatology, UBC and scientific
director, Arthritis Research Centre of Canada located
at VCHRI's Centre for Hip Health.
“People taking bisphosphonates are now hearing about
the potential side-effects, and this study result will
permit physicians to better inform them what the order
of magnitude of the risk may be” Esdaile adds.