June 2007
Revised June 13, 2007
Osteonecrosis of the Jaw
A number of recent medical reports have linked high doses of intravenous bisphosphonates given to patients
for the treatment of multiple myeloma, breast cancer or other cancers, to a condition known as
Osteonecrosis of the Jaw (ONJ).
Osteonecrosis of the Jaw typically appears as an area of exposed bone in the upper and/or lower jaw that
does not heal after a period of 6 weeks. It may or may not be painful. Most cases have occurred in patients
with past or ongoing treatment with intravenous bisphosphonates, usually in high doses for treatment of
cancer. Many of these individuals have been on other medications for their cancer. It appears that in
addition to the bisphosphonate therapy, most have undergone some dental work such as tooth extraction or
dental implants or treatment for an oral infection or had other local trauma to the oral cavity prior to the
development of ONJ. In a few individuals, there was no history of dental work or injury prior to the
occurrence of ONJ. It is reported that individuals who develop ONJ have been on bisphosphonates for some time
(the average duration of treatment was approximately 2 years) prior to the development of the lesions. ONJ is
treated by dentists or dental surgeons with local treatment to the mouth such as rinces, antibiotics and
local surgical procedures.
Oral bisphosphonates, such as alendronate (Fosamax®), etidronate (Didrocal®) and risedronate (Actonel®)
are often used in the treatment of osteoporosis. Infrequently, intravenous bisphosphonates such as
pamidronate or zoledronate are also used in the treatment of osteoporosis.
A smaller number of ONJ cases have been reported in patients receiving oral bisphosphonates for the
treatment of osteoporosis and/or Pagets Disease. These cases are quite rare and estimated to occur in
between 1 in 10,000 and 1 in 100,000 of patients taking oral bisphosphonates for osteoporosis. Unfortunately,
limited information is available about the dose and duration of bisphosphonate therapy and the general health
of the patients who developed ONJ while on treatment for osteoporosis or Pagets Disease.
To date there have been no reports of this condition in association with other medications used in the
treatment of osteoporosis namely calcium, vitamin D, raloxifene (Evista®), calcitonin (Miacalcin®) and
teriparatide (Forteo®).
The reports of ONJ in patients with osteoporosis have caused great concern among health care professionals
and patients alike.
Clinical Recommendations
At present, there is simply not enough medical information to prepare fact-based guidelines for the
prevention and treatment of ONJ in patients taking oral bisphosphonates for treatment of osteoporosis or
Pagets Disease. The risk of developing ONJ with oral bisphosphonates is known to be very low (between 1 in
10,000 and 1 in 100,000), however it would be prudent for patients on oral bisphosphonates for osteoporosis
to consider the following:
-
Maintain good oral hygiene by regular visits to your dentist and dental hygienist. This advice is
the same for everyone whether or not you are on a bisphosphonate.
-
Report any oral or dental problems to your dentist and to your physician. This
would include pain, swelling, problems with your gums or loosening of your teeth.
-
Inform your dentist or dental surgeon that you are on a bisphosphonate. Should your dentist be concerned
about this treatment and your dental health, he/she may contact your physician.
-
Some health care professionals recommend stopping bisphosphonates for several weeks before and after
invasive or traumatic dental work (such as tooth extraction or dental implant). Currently, there is no
proof that this will help prevent ONJ. However, given the long term benefits of bisphosphonates to
bones, it is unlikely that stopping these medications temporarily will have any adverse impact on the
treatment for osteoporosis. Always be sure to check with your own doctor first.
-
Routine dental work such as dental cleaning, fillings or root canals have not been reported to increase
the risk of ONJ.
-
ONJ does not cause any problems with the jaw joint. If you experience pain, snapping or cracking
in the jaw joint, this is not related to ONJ nor to your bisphosphonate.
-
Remember, the osteoporosis medication was prescribed to help you prevent a fracture (broken bone).
You are much more at risk of suffering a fracture than to ever develop ONJ. The benefits to you
are much greater than possible risks from these medications. You should always discuss with your physician
prior to stopping/changing your osteoporosis medication.
For the Future
Further research is needed to better understand the incidence and mechanism of ONJ, and to identify
specific patient risk factors which would predispose some individuals to ONJ when these drugs are used in the
recommended doses for treatment of osteoporosis and/or Pagets Disease.
Because of the urgency to clarify how and by what mechanism ONJ occurs, the American Society of Bone and
Mineral Research (ASBMR), has initiated a forum that would bring together physicians, oral surgeons, dentists
and scientists with expertise in key areas of the disease, to address this clinical problem and
together, provide further guidance into best clinical practices. The Scientific Advisory Council
of Osteoporosis Canada supports this endeavour.
Osteoporosis Canada will update this statement when new information becomes available.
Further reading
>> Article written by the American Society of Bone and Mineral Research on Osteonecrosis of the Jaw (ONJ). It is felt this article reflects the current and
most up to date research on this subject that has currently made news headlines linking ONJ with use of
bisphosphonates.
