Re: Bisphosphonates and osteonecrosis - from an OMFS
From: Meenan, Anna (annam@uic.edu)
Mon Jun 5 11:21:53 2006
I still agree with you, Kim. I'm really afraid we will be finding a
lot more cases now that this is known, and I prefer to wait til I see
how this all shakes out before aggressively promoting
bisphosphonates. And again, my gut feeling for myself is that I
would rather have a hip fracture than osteonecrosis of the jaw.
Really.
Anna Meenan, MD
>I agree that telling our patients is important. Risks, benefits and
>alternatives of ALL treatments. And yes, ultimately it should be a
>well informed patient who chooses which risks they are willing to
>take.
>
>As far as I know there are no significant side effects to a healthy
>calcium rich diet and exercise to build bone mass now.
>
>You are correct that it is a rare side effect (though I suspect now
>that it is "identified" the numbers reported will be increasing.
>Almost every OMFS that I know can look back through their case load
>and identify at least one patient, usually female, usually post or
>perimenopausal, who had a non-healing "infection" that required
>rather drastic measures to gain control).
>
>The landmark article (Ruggiero et. al.) reported 7 out of 63 (11%)
>cases (not 6 out of 300 as was suggested below) caused by oral
>bisphosphonate use. When you look at the large numbers of patients
>on oral bisphosphonates that becomes a very significant potential
>patient population. BAON is not just painful but deforming,
>disfiguring and life changing. Some of these women have lost their
>entire lower jaw necessitating G tube placement and tracheostomies.
>If you believe that drooling or a drooping face due to a stroke is
>deforming (and I agree that it is), then this is certainly a much
>worse deformity that is cosmetically and functionally devastating.
>
>OCP's increase the risk of clots. HRT increases the risk of clots
>and yet patients continue to take both of these. Smoking increases
>the risk of clots and does nothing good for patients and yet despite
>all our educational efforts patients also continue to smoke. All
>medications have side effects. Because we do not understand the
>mechanism here, because there are other methods for preserving and
>improving bone mass, because the potential downside is so great, I
>do not believe this is either an emotional or an illogical response.
>
>And hip fractures in the very elderly or infirm of either sex can
>indeed be the "straw that breaks the camel's back" but interestingly
>it is exceedingly rare for an elderly man to be placed on
>bisphosphonates unless he is also a cancer patient. The statistics
>below come from the British Medical Journal in a study that looked
>at mortality at 30, 60, 90 and 365 days after surgery for fracture
>of the femoral head and are food for thought.
>
>"fatality rates at 30 days in 1984-98 increased from 4% in men aged
>64-69 years to 31% in those aged >= 90. They were higher in men than
>women, and in social classes IV and V than in classes I and II."
>
>Now 31% seems like a very high number but so does age over 90. I
>hope I am kicking around and healthy at 90 but let's face it, the
>chances of mortality from any cause over the age of 90 should
>certainly be higher than the chances of mortality from the same
>cause at age 60.
>
>And osteoporosis is not the only factor in the increased risk for
>hip fractures in the elderly. Multiple studies show that age,
>underlying medical status, poor preinjury mobility, time spent in
>the ER prior to surgery, non-use of thromboembolic prophylaxis
>during hospital stay, male gender and poor discharge planning all
>contribute significantly to increased morbidity and mortality from
>hip fractures.
>
>So no, I do not believe this to be a "knee jerk" reaction. It is a
>reasoned response, not the only one mind you but the one I have
>developed after several years of consideration, constant review of
>the literature and at least 7 years experience taking care of
>patients who have had this devastating complication of
>bisphosphonate therapy.
>
>Interestingly, if you go to the very old literature, there was a
>similar phenomenon reported in workers in the match industry in the
>mid-19th century. These were mostly young, healthy people who were
>exposed to biologically active white phosphorus at their work place.
>Chronic phosphorus exposure appeared to induce hyperostosis of the
>entire skeletal structure and sequestration and nonhealing injuries
>in both jaws. The phosphorus appeared to be more highly concentrated
>in the jaws than elsewhere in the body. The mortality rate for this
>disease in the preantibiotic era was estimated at ~ 20%. The
>phenomenon was also seen in other industries where white phosphorus
>was used (munitions, fireworks, brass manufacturers) and appears to
>have been controlled and eradicated by industrial hygiene measures
>which resulted in workers no longer being exposed to this
>biologically active compound.
>
>It is all food for thought.
>
>On Jun 5, 2006, at 1:26 AM, Rafael Haciski wrote:
>
>>Isn't that a bit of an emotional response, and an illogical one at that?
>>
>>Being fully cognizant of the unpleasantness of osteonecrosis, and
>>also acknowledging the probable underreporting of the incidence,
>>the facts remain:
>>.. ONJ is an exceedingly RARE event, (my understanding of the
>>reported incidents is that there were approx. 6 cases out of 300
>>who were taking oral bisphosphonates, the rest were on IV);
>>.. the denominator are the millions of patients on oral bisphosphonates
>>.. on the other hand, the incidence of bone fractures related to
>>osteoporosis is close to 1,500,000 per year in the US
>>.. in menopause, fatalities due to complications of hip fracture
>>reach 30% within the year of fx
>>.. Evista, HRT carry also the risk of DVT (you do not like what
>>osteonecrosis may feel like, but how about drooling out of your
>>mouth, being a paralyzed vegetable due to DVT?)
>>
>>If your logic were sound in trying to avoid this exceedingly
>>uncommon complication, then you should avoid the much more common
>>risks of other medications you mention, and indeed, you probably
>>should stay at home and never venture out, as driving is the single
>>most dangerous activity we undertake. Yet we choose to do it every
>>day.
>>
>>We really have to moderate our knee jerk reactions, especially as
>>those reactions filter out to the public who become totally
>>confused by our fears and lack of understanding. WHI comes to mind
>>- the premature release of incompletely digested and understood
>>data caused much confusion and has been a disservice to our
>>patients, and an added burden to us trying to explain to our
>>patients what is going on and what they should do.
>>
>>At present, all I can tell my patients are the risks as we best
>>understand them of BOTH sides of the equation, and let them choose.
>>
>>Rafael Haciski MD FACOG
>>Palmetto, FL
>>
>>On Jun 4, 2006, at 2:59 PM, Meenan, Anna wrote:
>>
>>>Thank you so much for posting, Kim. Those have kind of been my
>>>gut feelings since this story broke, and as a 52 y.o. thin,
>>>half-Danish woman with a family history of osteoporosis and a
>>>T-score of minus 1.8 (4 years ago, and I'm too chicken to get
>>>another BMD now), this affects me personally. I've really been in
>>>a quandary, because I know it's gong to come up at my next annual.
>>>I also have an extreme case of dentalphobia, and even the thought
>>>of someone digging dead pieces of bone out of my jaw gives me the
>>>creeps.
>>>
>>>Anna Meenan, MD
>>>
>>>>I noted with interest that this topic is being discussed in OB-GYN
>>>>forums and thought I would share what little we actually do know about
>>>>this phenomenon. It is, unfortunately, very little but, as many of you
>>>>have pointed out, the attorneys are ALL on to this already. It has been
>>>>relatively well known in the oral surgery community for several years
>>>>now but seems, only recently to have disseminated beyond that relatively
>>>>small group of health care providers.
>>>>
>>>>1. Bisphosphonate related osteonecrosis (BRON) occurs in a very small
>>>>percentage of patients on bisphosphonates but when it does occur it can
>>>>be devastating.
>>>>2. BRON is more common in patients receiving IV bisphosphonates but
>>>>ABSOLUTELY DOES OCCUR in patients on oral medications only for the
>>>>prevention of or treatment of osteoporosis.
>>>>3. In many cases there is some minor oral injury (tooth extraction,
>>>>denture sore, etc.) which precipitates the disease BUT THERE ARE ALSO
>>>>CASES WHERE THIS OCCURS SPONTANEOUSLY.
>>>>4. Taking patients off bisphosphonates may not lower their risk for an
>>>>extended period of time or at all. We just don't know. We do know that
>>>>bisphosphonates have a very long half life in bone.
>>>>5. As of yet, there is no clear consensus on treatment though there is
>>>>a great deal of work being done on clarifying and stratifying treatment
>>>>modalities. It is still, quite often, a disease with extreme morbidity
>>>>when it occurs.
>>>>
>>>>I believe that we will see increasing numbers of these cases reported.
>>>>
>>>>Personally, I have looked backward through my own cases and know of at
>>>>least one case in the late 90's which must have been BRON.
>>>>History is
>>>>as follows. Otherwise healthy female (nurse at our hospital actually)
>>>>in her late 50's whose only medication was a bisphosphonate. Saw her
>>>>dentist, had tooth extracted, site didn't heal, tx'd with abx without
>>>>resolution, referred to OMFS, multiple debridements without healing,
>>>>referred to our teaching hospital where multiple services including ID
>>>>were involved, workup for immune deficiency was negative, PICC line and
>>>>long term abx failed to resolve issue....long story short she eventually
>>>>lost almost half of her lower jaw.
>>>>
>>>>Since that time I have seen, treated or had colleagues in our practice
>>>>treat several other cases. While the occurences are still relatively
>>>>rare, as I stated before, when it is you or your patient, it is
>>>>devastating.
>>>>
>>>>I am often asked by patients now what they should do about these drugs
>>>>and my personal suggestions to patients at this point are as follows:
>>>>
>>>>First I share with them how little we actually know about this problem.
>>>>For patients who will understand, I also provide copies of some of the
>>>>landmark papers on the issue (Ruggerio et. al, Marx et. al.) I then
>>>>share the following personal philosophies.
>>>>
>>>>1. No matter what your age now is the time to increase calcium intake,
>>>>increase exercise and healthy life style choices, build bone mass now to
>>>>prevent problems later.
>>>>2. I would not personally take a bisphosphonate for prevention of
>>>>osteoporosis.
>>>>3. If I were already diagnosed with osteopenia or osteoporosis, I would
>>>>look into nonbisphosphonate modalities such as Evista and HRT.
>>>>4. IF *I* were on bisphosphonates I would discontinue them even knowing
>>>>that we don't know if this is helpful or reduces risk long term.
>>>>Teleologically it seems unlikely to reduce short term risk given the
>>>>long half life of these drugs.
>>>>5. For cancer patients who will be placed on IV bisphosphonates I urge
>>>>restoration of dental health prior to beginning these drugs (as is also
>>>>advised prior to beginning chemotherapy or XRT)and patient education to
>>>>understand the risks/benefits of such drugs in these cases.
>>>>6. I encourage patients to discuss these issues with the health care
>>>>provider who is suggesting or prescribing bisphosphonates and always
>>>>offer to discuss the OMFS literature and experience with those providers
>>>>so that together with their health care providers they can make the best
>>>>decision for their individual case.
>>>>
>>>>--
>>>>Kim E. Goldman, D.M.D.
>>>>Associates in Oral & Maxillofacial Surgery, PLC
>>>>Asst. Clin. Prof. University of Louisville
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