Re: Bisphosphonates and osteonecrosis - from an OMFS
From: art fougner, md (evsono@pipeline.com)
Mon Jun 5 13:28:27 2006
It's enough to want to return to writing ERT Rx's again.
art
At Mon, 5 Jun 2006, Meenan, Anna wrote:
>
>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
--
art fougner, md
"I drank what?" - Socrates
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