Oral Bisphosphonates, Osteonecrosis, and Dental Implants

As a periodontist, I have performed several hundred surgical procedures on osteoporotic and osteopenic patients. In the past year, I treated one patient taking Fosamax, with extractions and sinus graft procedures. The clinical healing was representative of the published cases of osteonecrosis. When I contacted the patients physician for medical approval to discontinue Fosamax for about one month, she informed me that all patients in her office are told to discontinue oral or injected bisphosphonates when treated for fractures. Their rationale is to prevent impaired healing related to bisphosphonates. I just thought that this case was worth reporting to Osseonews readers.

I have treated many many osteoporotic patients with implants, and in fact lectured and published on the subject. I saw no contraindications to treating them as long as they were treated with care. Now I am very concerned about placing them in patients who have been taking these medications. Certainly these patients must be given proper informed consent. The scary thing is these drugs are being marketed to practically every aging woman in the world. I think there needs to be a way to get the word out on this side effect that dentistry seems to know about before medicine does.

I have experienced the same with a patient taking Fosamax on mandibular implants. She has since lost the 2 implants for the molar and premolar areas. She is finally on the road to healing, but had to combat a superinfection with Actinomycosis as well. If a case comes up, doing debridement is not the treatment, nor is hyperbaric oxygen. You need to get rid of the oral bisphosphonate for about 1 to 2 months and treat with clindamycin 150 mg tid for a month. This combination really works well. No research, but it's worked!!

I have now seen 12 patients in my OMFS practice that have experienced Osteonecrosis either due to recent extractions, periodontal surgery, and three that have had spontaneously exposed tori or alveolar bone (one denture wearer). This has been over the course of the last year. I can recall however, the placement of bone grafts in advance of dental implants in several patients. It has been my experience that the graftd sites had type I bone that was great for primary stability, but went on to have failed integration. In talking with a Hematologist/Oncologist regardign the bisphosphonate dilemma we are experiencing, it has been her recommendation to have patients that have been on these medications for more than two years consecutively to either go to a monthly maintenance dose, alternate months, or discontinue entirely depending on the patient's clinical situation. Having tried to debride the areas in some of the patients, only to have soft tissue breakdown, to follow, I have discontinued this procedure six months ago. Two of the patients went on to have hyperbaric oxygen therapy, yet continued to have bone exposure. It is my opinion that Osteoblast/Osteoclast axis is shifted so far to the right as to generate bone that no longer has the vascular capacity for repair or remodeling and hence becomes necrotic with no forseeable end in sight. JOMS Vol 63, Number 11, Nov 2005 has a great review article on the subject for those who would like more information. DAS

At this time it appears from published studies in peer reviewed journals and many anecdotal reports that ALL patients receiving oral bisphosphonates are at risk for developing osteonecrosis of the maxilla and mandible. Originally the focus was on bisphosphonates delivered via IV. However the mechanism of action of oral bisphosphonates is the same as those delivered via IV.

Having read thoroughly the articles penned by Dr Robert Marx from Miami, I will not place implants in individuals taking the drugs until further evidence shows evidence they will not cause the necrosis. I trained under Dr Marx, and his opinion is good enough for me. At this time, I have seen delayed healing with the oral forms, and I have seen one case with the IV form. According to current information, stopping the drug does not help as it remains in the body for at least 10 years. Until this is resolved, I believe the implant market for these individuals is hindered. All it takes is one case of total necrosis to wipe out a thousand successes.

Oral bisphosphonates may actually emerge as a more siginifcant problem simply because of the vast number of people taking them. Now that we are all more aware of the complications of bisphosphonates maybe we will have more cases being reported yielding more data for analysis.

Latest information from peer discussions relative to word from Harvard oncologist is that while Fosamax is a Bisphosphonate, there is a chemical structural difference and a shorter half life. Recommendation is that Fosamax is discontinued for 3 months after which oral surgery can be done with relative safety. Probably good to use prophylatic antibiotic coverage. After "healing" Fosamax is continued. How this relates to implants is a matter of speculation. I'm unaware of literature relative to this at this time. I'd certainly be interested in more information regarding this anectdotal posting before doing implants.

I had upper and lower dental implants a year ago. Today my doctor prescribed Fosamax plus D...NOW I'm worried about taking the medicine..I don't want all my implants to fall out! Input please ! I'm 58 and have osteopenia in the hips..just diagnosed.

Emory School of Medicine CE course last month provided me with enough information that would NOT have me consider any implants for these patients. I think we're about to see a major problem grow even bigger.

Double trouble; I have a patient who had a carcinoma of the base of the tongue treated with radiation successfully in 1997. In the last year he started Fosamax. He presented with a large necrotic area in an edentulous space distal to a lower first molar with a periodontal pocket. I've referred him to an endodontist for treatment of the first molar. We've (his ENT, internist and I) discontinued the Fosamax and have the patient irrigating with chorhexidine and have had him on Clindimicin. Could this have started as a mucositis on the lingual side of the mandible? (Fosamax is noted for esophogitis) Time will tell on the success of our treatment plan.

As an Implantologist/General Dentist I am very concerned with the bisphosphonate attention. I do my best to educate my patients of the risks of osteonecrosis of the jaws. However, when the pts consult their attending physicians the pts are being told that dentists are being overdramatic and there is no need to be concern. What do DDS' know that MD's don't?

I had a single case of osteonecrosis with implant placement. Implants had to be removed, bone debrided and closed. Patient was taking Fosamax and methotrexate.

Anyone have any idea why bisphosphonate related osteonecrosis appears to be limitted to the maxilla and the mandible? The general population that is taking the oral bisphosphnates, such as Fosamax, mostly AARP eligable people, certainly includes many who have had knee or hip replacement surgery. Why wouldn't we be getting reports of osteonecrosis complicatons with these procedures?

Is it possible that the incidence of O.N. seen in the facial skeleton may be that these bones are intramembranous versus the rest of the skeleton being endochondral bone? It might be an excellent literature review to see if there has been incidents of O.N. at the interface of prosthetic joints, especially those made of titanium as are our beloved dental implants. Perhaps it is a specific interaction with titanium and the facial osseous tissue altered by bisphosphonates.

In my old publications I stated that osteoporosis is seen in the maxilla and mandible even before it is the rest of the body (especially in edentulous patients). We may just be seeing the tip of the iceberg. Regarding MD's they are not omnipotent, we are the ones who find the most oral cancer, and I have had MD's refer me pizza burns for biopsy. Dentists know far more about oral disease than MD's, and this is as it should be.

Dr. Baxter, I agree that dentists should know more about oral disease than MD's, as an Internist should know more about hypertension. The truth is far from that, as most dentists have tried to make their practices more profitable by acting as specialists without the proper technical training, knowledge and most importantly they fail to recognize their limitations. Remember, failure to diagnose is a very common allegation against General Dentists and this a trend that worsens daily.

Iam an OMF Surgeon from Brisbane, Australia. I have recently seen a case of Fosamax-induced ONJ of the anterior maxilla, which was initiated just by the wearing of a partial upper denture. The frightening thing about it was that the elderley patient had been on oral Fosamax only, and had been off the drug for at least 3 months, before the ONJ set in. My colleagues are coming around to the conclusion that there may not be any real "safe" period to be off Fosamax before doing any Oral Surgery.

I have seen some interesting comments and questions posted regarding Bisphosphonate induced Osteonecrosis of the Jaws. Most clinicians only see a few of these patients in their practices and aren't sure how to treat them. I invite the readers to review our article published in JOMS, Nov.2005 for a thorough review of our findings in 119 patients. I would be happy to e-mail the article to those without access to the JOMS. Vishtasb Broumand, DMD, MD Oral & Maxillofacial Surgery Head and Neck Tumor and Reconstructive Surgery Assistant Professor of Clinical Surgery Division of Oral & Maxillofacial Surgery University of Miami School of Medicine/ Jackson Memorial Hospital 9380 S.W. 150th Street, Suite 170 Miami, FL 33157 E-mail: [email protected]

As an Oral Surgeon from Sydney Australia I have been referred three cases of Bis-Phossy Mouth -- two in the maxilla and one mandibular one in the 3rd molar region. It would appear that the reason why the Bisphosphonate Osteonecrosis occurs only in the maxilla or mandible is because they hold teeth (and implants) in an interface of periodontium (or peri-implantium) which is prone to inflammation and contamination. Nowhere else in the body does such an interface occur. It makes one think about the placement of implants for patients who are yet to be diagnosed at osteoporotic.

In the last 3 years, I have seen about 4 patients in which my referring dentist took out periodontally involved teeth and they did not heal. All of them were taking Fosamax. I extensively followed two patients and performed multiple debridements on them. One of them finally healed 18 months later. The other one is still not healed. After the first two patients, I refer all osteonecrosis post extraction to the university. Not sure if they can do much either. In these cases, doing less maybe better! I would not place implants in a Fosamax patient.

Go to www.powelllaw.com - they know about the problem and will help YOUR? patient! This is posted on Drug.com but nothing in side effect of the biophos's lists bone issues.

My wife has been taking fosamax over a year for early osteoporosis. She is 56 yrs old. She has pretty good teeth; but after reading all these coments I'm concerned for the future. Should she discontue using this drug? Are there any other treatments to prevent or reverse osteoporosis that do not have this potentially serious side affects?

Lawrence, besides being a Prosthodontist, I am getting to the age that bone loss is an issue with me, especially with a family history of osteoporosis. Personally I won't be touching these drugs witha 10 foot pole.

Crystal, Good to see you still can deliver that "sharp" commentary. This problem is new to most of us and will only become more visible with time. Thanks to everyone for posting their experiences and comments-it has been very helpful. Herm D.

Does it make a differance if Fosimax is taken oraly or by injection?

In November 2005 I developed a sore spot on the outside of my lower jawbone. The diagnosis was that there was a problem with a root canal on the back molar and extraction and implant was suggested. The extraction had some problems healing but is now fine. However, my implant doctor is now questioning if my use of fosamax for the last year presents a caution about the implant. The sore spot on my jawbone has never gone away. Is that sore place a possible indication of a problem with the fosamax? ie ostrnecrosis?

My daughter has Fibrous dysplasia of the right maxilla. She has had IV Pamidronate in February of 2004, she had surgery at CCF in May of 2004 where they just shaved down part of the bone and she had IV Pamidronate September 2004, and March of 2005. I am obviously concerned about all the info on osteonecrosis and she is in need of having her wisdom teeth removed and I am unsure whether to 1-have her wisdom teetch removed only one is causing an issue and 2-the decision to continue the Infusions for her treatment of FD. thank you

concerning Comments posted by dr Robert marier i will say,unfortunately half life of bisphosphonates last years thus stopping the drug has little or NO EFFECT on clinical issu

I have been taking fosamax for 1 1/2 years and recently had an implant which seems to have healed. My dentist has informed me that he would not do another implant on me. Is there another medication? Is it possible that further research will find a medication to counteract the problems with fosamax?

Any thoughts about the bone banks screening donors for previous use of these medications? I do not know of one that is doing that at this time, but I would be concerned about placing a graft from a donor who had been on these medications.

Placing implants in these patient's is an attorney's dream. This is our next big malpractice catastrophe. Use all means to keep from surgery if possible and we can avoid these problems. When surgery is the only choice left then do it, but not elective implants. Just my opinion.

I'm 53 year old female w/ osteoporosis who recently discontinued Actonel after 1.5 years. This was after a 73 year old friend taking Fosamax developed jaw problems that may be osteonecrosis. My PCP agreed for me to go off the med pending a DEXA scan which has shown no change (side note: I am recovering from Celiac Disease); now he wants me to go back on it. I'm afraid of this medication! This may be the next Vioxx, the next HRT. I've started electromagnetic therapy using the QRS device and I'm going to take the Ostea Mins supplements which include strontium. I've perused the scientific research on these alternatives and think they are both promising if not solidly proven. Meanwhile, I'm getting extra serious about exercise, particularly looking into jumping rope! Although I am a layperson, I don't like the sound of the osteoclast/osteoblast unbalancing action of the bisphosphonates. I also don't believe there is enough long-term safety data. I hope the medical community will continue valuable dialogs like these.

any news regarding implant placement in patients under oral bisphosphonates

I think it is essential that our professional organizations start a massive public education campaign on the dangers on Fossamax and related class products. Also all the dental implant manufacturers should get on board with this as well as this will cut into their sales in a big way! TIME IS OF THE ESSENCE! Rik

Since posting a sign asking if patiens have taken a bisphosphontes, we have been suprised of how many men are also taking this drug. its not just a female problem.

I'd placed three implants in one of my patient three years ago. The implants looks great on x-rays and exam show the soft tissue to be healthy. But the patient could not use them. It felt sensitive upon mastication, yet everything looked great. Later I was informed by the patient that she was taking Fosamax. After consulting with patient's MD, patient stop taking the Fosamax. After about three months patients stated she was able to chew on the implants a little. Now, about 12 month later patient stated she can chew on the implants with little discomfort. I am very concern with patients taking Fosamax.Right now I am not comfortable doing implants on patients taking Fosamax.

Having read above....Fosamax is a contraindication for oral surgury and implants. BUT....if that should happen with statin drugs we will not be doing dentistry for anyone. The Fosamax tpye medication is becoming like vitamins. We have to find a protocal for treating these patients and determine at what level can they be treated and with what precautions

Reality is..NO ONE understands it enough to setup a protocol or takes it seriously. It might take few lawsuits to get noticed. Problem is professional dentistry is failing to setup a reasonable protocol. My suggestion is as follows. If a patient is on BP less than 2 months, then discontinue with dr's help, wait 60 days, place implant and think about NEVER placing patient on BP again. Those who are on BP, half life is 10 years, so no chance of stopping it and treating pt's like on coumadin.For these patient, treatment plan is NO SURGERY of any kind. FDA has posted recommendation from an expert panel setup by company NOVARTIS that makes Actenol. My presentation explains that article and protocols. Following is the link for my presentation as well as 2 articles on BP-ONJ. http://www.cyberdontic.com/OSG/bponj.htm Please feel free to share this link. My presentation represents compilation of data from various sources and according to me, these 2 documents provide a much needed protocol that we need to adapt. Interetingly..yesterday as I was speaking to my study group, one of the participant dentist was browsing through yesterdays Newsday(Long Island Newspaper) and he brought an ad to my attention...an attorney trying to solicit patients who are on Fosamax mentioning osteonecrosis /dead jaw. Last week on a Saturday as I was driving to my office, at 7.58 am in the morning, there was an ad soliciting clients from an attorney related to Fosamax alone. On the internet and TV there are already attornies litigating this issue way before dentist as a profession is learning how to manage the condition or the issue itself. Ad in a Newsday is too close for comfort for us in New York. Hopefully, you will find my presentation useful and we together as a group and individually as practitioners, we will make a difference for our patients and us.

Gratefully there has been a dramatic increase in public awareness of the side effects of bisphosphonates relating to oral necrosis of the jaws (OJN). JADA and JOMS articles have been referenced above. Much of the remaining data is anecdotal and based on observation. This is a great place to start. AAOMS has initiated a data base of OJN cases for better understanding of its incidence and natural history. Further case reports should be submitted to a peer reviewed study center. The medical industry is taking notice of these efforts. These observations should be weighed with the benefits to osteoporotic disability in the elderly. As in significantly irradiated jaws where the incidence of ORN is 35% not 100%, further understanding is needed before cogent recommendations can be made. Until then a conservative approach as described in JADA seems prudent to me.

Clarification I have a 17 year old daughter that has received aredia infusions for the past two years. We are being told that the patients being dx with ON are those who have also had chemo, radiation, etc. I have been following this discussion for several months and decided to discontinue her infusions. Is this the case that the majority of the patients being dx are those who have been treated for cancer or are they just patients who have received just the biophosphonates? Multiple opinions would be great from physicians as this is quite scarey to have a child receiving these for several years and is in need of extractions. Thank you

It should be quite obvious to everyone reading these comments on Fosamax as well as all the other froms and methods of delievery of bisphosphonates that we are at risk in surgically treating these patients. Not only for implants but any surgery of the jaws. Alveolar bone by it nature, not neccesarily histologicly, is considered to be a more highly metabolic bone, constantly subjected to trauma, potential pathogens, and many times has a direct link to the oral cavity. Any patient on medication that will alter the normal responce to bone healing and repair needs to be very carefully evaluated prior to treatment. That being said, what does that mean? Patients have been known to develope spontaneous problems that may be related to the above. We advise all our patients of the risks and benifits of all our surgical proceedures and at this point select those that are in our opinion at low risk. It is always advisable to discuss any future treatment with the prescibing physician and depending on the immediacy of treatment, reason for being on the medication etc. adjustment or discontinuence may be advisable. Patients on these drugs need to be very well informed and understand there risks. Just as another personal comment, since being aware of these problems we have been more prudent in patient selection for surgery but have yet to see on our relatively busy OMFS practice implant loss, infection or necrosis of bone that we can attribute to our patient population on bisphoshates.

I would suggest that all readers of this dental implant site look at and evaluate the ADA's Council on Scientific Affair's Consensus Statement in regards to the issue of Osteochemonecrosis (OCN) as it relates to bisphosphonate therapy. There is no issue with the effects of IV based nitrogen based BisPhosphonates causing OCN is real. The role of the oral bisphosphonates on the other hand has a number of issues to consider. There are dramatic differences in the nature of the dose, potency, length of duration of exposure, half life and con-founding drugs and systemic conditions the patients has whom are on oral bisphosphonates medications. One example is the role of periodic bust corticosteroid therapy for Osteoarthritis. A careful and though medical history of each patient including queries about previous use of any medication to manage osteoporosis (or osteopenia) at ANY time in the patient’s history is critical. Remember, the half life of these medications is in decades not years.

Until we have more data, I will consider oral biphosphonates as a relative contraindication to extractions and implants. Many of my healthy patients have successfully had implants integrate and restored. I am very concerned about the patient taking biphosphonates who is a smoker or a poorly controled diabetic, or who possibly has another comorbid condition that might compromise the blood supply and healing to bone.

We have a number of patients treatment in our department who were on oral bisphosphonates. I agree that not enough is known about this entity to have definitive recommendations, but it is wise to consider it a relative contraindication. For a intresting perspective on this issue in contrast to Dr. Marx's recommendations on management, please see a letter published in the JOMS this month by Dr. Harry Schwartz.

It is important for those practioners who view this site to understand that no controlled studies have been conducted on these drugs and the management of osteonecrosis. Because osteonecrosis is at this point in time, an incurable disease, it would behoove practioners to NOT perform extractions unless no other option is available and certainly to NOT place dental implants into these patients unless they are fully informed of the risks. The half-life of these medications is decades long and no one knows with any certainly when it is safe to perform invasive procedures after cessation of the drug! I believe that dental implants are an absolute contraindication in patients who have taken bisphosphonates.

Let's not panic. For a decade, oral surgeons have knowingly been performing all manner of surgical exodontia and jaw surgery on patients taking the ORAL drugs (Fosomax, Actonel). We all know that the vast majority of our surgical patients who were on oral BisPhos, did NOT experience osteonecrosis. Like diabetics, patients on long term corticosteroids, HIV, and other compromised hosts, there will be complications in some as yet undetermined percentage of BisPhos "contaminated" individuals. Unfortunately, and possibly intentionally, the September, 2006, ADA Journal article did not give us the a standard of care which if followed, would repel litiginous opportunists.Perhaps routine use of the AAOMS Standardized Informed Consent Document for BisPhos users is a first step, followed by an empirical (for now) period of discontinuance of use prior to elective procedures. To suggest in this blog,as some authors have, that extractions should be prohibited in oral Bisphos patients, is inflammatory rhetoric not currently justified based on our collective anecdotal experience, is not based on any prospective scientific peer reviewed study, and is cruel to our suffering patients. I suspect many actively practicing OMFS have already come to the conclusion that for the time being, when possible, for elective procedures, patients should be off these drugs for the longest practical interval, and perhaps receive a longer than usual course of p.o. antibiotic therapy.To suggest here that extractions are contraindicated, is to be a sialogogue to those in the legal professions who are drooling at the thought of using the opinions suggested here as Gospel. Let's be cautious and help those who need data, to accumulate it, but let us not jump on a bandwagon that may inadvertently run over some of the very patients who need our help the most. What's your opinion?

O.N. seems to hit approx 6 to 10% of patients taking I.V. Biphosphonates. It looks to be less risky with patiens taking them orally. I'm believing, for absence of fact, that it is more a problem of local vascularization plus osteoclast inhibition the reason for a O.N. in the jaws. If the bone remodeling is out of service, what may happens to the rest of the skeletal bone? Osteocytes, to my knowledge, aren't immortal cells, and they are replaced via the remodeling process. If osteoclast cannot remove the bone because of the drug, like the infected bone into an extraction socket, and obviously can't process the immature one to mature lamellar bone, there is no way a dental implant may osseointegrate. BTW, would it be sufficent to carefully inform the patient prior to any surgery in his/her mouth, to avoid legal issues?

Dear Dr Bozzi, Could you tell me where you got the figure "O.N. seems to hit approx 6 to 10% of patients taking I.V. Biphosphonates" I am not aware that the risk has been quantified. Do you also happen to know what % of patients requiring IV bisphosphonates would suffer crippling fractures or hypercalcaemia without it? Kind Regards, Bill Schaeffer

this is the official statement from the American Association of Oral & Maxillofacial Surgery. This is important for ALL dentists to read and be familiar with... especially to educate our patients, and our MD colleagues. http://www.aaoms.org/docs/position_papers/osteonecrosis.pdf

I am scheduled for hernia surgery. My surgeon told me to stop fosamax two weeks before the surgery. Is there a general problem of bone healing when on this drug?

Dr. Schaeffer asked for a reference regarding the statement that "6-10% of patients taking IV bisphosphonates may develop jaw necrosis". The reference is: Durie BGM, Katz M, Crowley J. Osteonecrosis of the jaw and bisphosphonates. Letter to the Editor, N Engl J Med. 2005; 353: 99-102. There was another interesting letter to the editor in last weeks New England Journal of Medicine (November 9 issue) from a group at Washington University medical school. They describe a 35 year old patient with high turnover osteoporosis who was treated with oral alendronate for five years. After five years he had markedly less bone density than before and was experiencing more fractures. What was most disturbing to them was that these fractures were in areas of cortical bone. They speculate that suppression of bone turnover caused by the bisphosphonates made his bones less able to heal and withstand stress induced fractures. This may have ominous implications for dental patients who clench or grind their teeth or who are contemplating adult orthodontics.

I have had a lot of dental work, 7 crowns and one implant over 3 years ago. I have been taking Fossamax for the past 18 months and I have just discovered this site. What exactly is the difficulty with fossamax. Ought I visit my dentist again?

Thanks for the info. I have osteonecrosis and am getting ready to go consult for anything to get rid of this mess. I never took the bone drugs. I have late stage lyme disease and a positive cavitat for osteonecrosis. It certainly fits the pattern of overt failure in my mouth, having replaced bridge after bridge and tooth after tooth many times. No matter how compliant I am, the bottom falls out time after time. Flossing breaks teeth, taking floroquinolones perhaps produced an adverse fluoride reaction. ( I do that with many many meds... like staying awake four days after taking a single 30 mg phenobarbital for a stomach disorder a long time ago... very vivid). So I am taking iodine as an antidote to a possible fluoride reaction and waiting to see what in the world anyone thinks might keep me chewing in the long run........ But the teeth are really connected to the jaw bone and it's really connected to the neck bone , etc etc.

As a general dentist who has treated a vast number of geriatric patients in long term care facilities over the past ten years, I have seen the use of oral bisphosphonates skyrocket in the last couple of years as a buffer against the effects of osteoporosis and the spontaneous skeletal fractures that occur. Before the bisphophonate induced osteonecrosis complication was known, I did hundreds of extractions on patients who were on actonel and fosamax and to date have not had any known incidences of osteonecrosis. Most of whom had been on the drug two years or less. I feel that one of the reasons I have been so fortunate (blessed)is that most of these patients had either only recently started taking the bisphophonates or had been on the bisphophonates two years or less. Less than 5% of residents are in long term care facilities for more than two years. I believe that there is a direct correlation between the possibility of osteonecrosis and the amount of time the patient has been on the bisphonate, which would explain why we are seeing more of these cases, as compared to years past, as patients have now been taking the drug longer. Also, this could explain why discontinuing bisphonate therapy works for some and not others. Though this drug has had remarkable success in helping to prevent spontaneous fractures in long term care residents, I believe the medical community should develop more stringint guidelines as to when someone should be prescribed this drug and only to prevent spontanous painful fractures in the elderly or to utilize bisphonates when all other options have been exausted.

I am a 66 year old female due for a first dental implant soon. I am healthy but with some family history of osteoporosis. What might be the risk to a healed implant of starting a bisphosphonate in a few years time if I were to develop some osteonecrosis as a result?

Gentlemen and Ladies. I need input on this bisphosphonates subject. I pulled my name from this only to avoid possibly being watch listed for future intervention by our legal friends. I placed 5 endosseous implants in the posterior (two on one side and three on the other) maxilla, all into healed healthy bone and 5 in the posterior mandible, healed healthy bone. The history was rather complete and unremarkable in reference in proceeding with implants. The patient actually is a nurse, and provided us with a hand written list of numerous medications she takes. I checked with her physician and he had no problem proceeding. The surgery went extremely well with no postoperative problems of any kind. The sutures were removed within one week. The initial surgery was 4 weeks ago. Today, 4 weeks post op she calls the office and asks when she should restart her Fosamax!!!. This was the first I heard about this. She also said she had been to two other oral surgeons prior to me (I am an general dentist with 30+ years of implant experience, both surgery and prosthetics with hospital post grad training) and they had refused to proceed with implants unless she would sign a release for placement since she told them she had been taking Fosamax. My most urgent question is: What has been done is done. The implants are in place. At this point all is well. If I am going to get osteonecrosis when would I begin to see the symptoms? what will those symptoms be? what will the course of treatment be if I do get the symptoms? She also needs a couple of extractions that I was going to do after we get implant healing, should they be removed (they are restorable, but she wants them out (two second molars) If the world were perfect!!, this would not happen and all will go well. If there are no problems the world would then be perfect, but??!!

In reference to my post above, I am aware of the total lack of awareness of physicians regarding the interaction of bisphosphonates and the dental bones. My primary purpose of checking with him was to see if my surgical protocol should be altered due to any medications or conditions the patient was being treated for. I checked the medications list the patient provided against their uses and none had anything to do with osteoporosis. She had listed arthritis and was taking methotrexate (sp?) for that. I learned another use is for osteoporosis and perhaps should have been a flag. I do not believe this drug is a bisphosphonate?

you said it. What is done is done. I had the same thing happen to me but the patient was on Zometa. My heart fell to the floor. Marx reports the incidence of OJN to be 2.3%(out of 23,000000 pts) The risk is low but is still there. You can order a blood CTX test to check the level of boneturnover and if the score is less than 150, the risk may be more relevant. With pts on bisphos., ctx testing is a must in my practice. If they areless than 150, i check with the MD to take them off until the scores rebound to a safe place. Marx's research shows that as long as the scores are above 150, patients are safe for any elective procedure. Remember, ojn is related to a surpression of boneturn over. We need bone turn over for what we do. An ounce of checking(prevention) can make you sleep better. The odds are in your favor. Good luck

Just the simple fact that someone else has faced this ultimate potential nightmare has made me feel a little better. Dr. Klassman what is the reference you use for Marx? Also how many zeros are there in that quote? Is that 23,000? At least the 2.3% is something I can hang on to. I have scheduled the patient to come in on Monday (in 5 days) to check on the healing. I intend to ask her why she withheld this vital information. She will also be given an order for the CTX blood test. Thank you very much

All this issue regarding osteonecrosis may well be overcome with Biomimetic's rhPDGF-BB that just gained orphan drug status. Does anyone know if any of the implant manufacturers have an agreement with the company?

Recently had patient with complaint of soreness between # 12-13-patient had developed open contact and gingival puffiness. probing revealed 10 mm pocket, rest of mouth within normal limits-placed restoration to close contact and placed patient on antibiotics--clindamycin 150 mg tid. After several weeks of no result ppulp test on 12 shows no vitality--no hont of periap lesion -felt tooth might be cracked. FLAPPED, CHECKED 13 FOR CRACK-REMOVED 12-NO CRACK READILY EVIDENT--PATIENT-MALE EARLY 60'S had been on fosomax--had recently ceased--area seems to be healing slowly. Fosomax possible culprit for this exaggaerated response to this inflammation in this area?

I am anoymous of January 30,07 We are now 9 weeks post op and the patient was just into the office today for routine followup. PA xrays were taken and all implants look great!! A couple of the healing caps had come loose but no problem otherwise. I discussed the situation with the patient regardng the Bisphosphonate she did not disclose and that there was one tooth she wanted extracted after implant healing. It is restorable and I told her I would not push our luck,and would not extract it. My intent is to restore it if all continues to go well. I will keep all up to date as this case continues. So far so good.

Dr. Klassman Where can I learn more about the CTX test and it's application to screeening dental implant candidates? Is there some parameters in the literature about the 150 score? Thank you

We have seen a number of bisphosphonate patients and they are problematic. What you all must understand that by just stopping the "fosamax" for a month or two does literallly nothing. The time cycle for these drugs can be over ten years. So now the bone is salted with "poison" for osteoclasts, the enire ecosystem is disrupted. This eco-disruption now allows for what we see clinically. Our group treats these patients with Oxygen/Ozone therapy is works very well at the biologic level. A tremedious infections killer, inhanced circulation to the area, immune booster, stem cell enhancement, etc. It is a very safe and effective treatment. We also support the area by infusing with cyto-nutrients.

this seems to be an issue that will not go away. the incidence of occurance of osteonecrosis in the jaw related to oral surgery and bisphosphates is not predictable. the iv form of administration is more likely to cause problems for the dentist but having had a phosomax petient develope osteonecrosis in her maxillia after a tooth extraction is an ugly situation. a problem which must be researched as so many people take these drugs and so many of them need extractions,while implants are a choice.

I have been taking Fosamax for 5 years. I have a #4 upper bicuspid with a crown and root canal. The crown broke off at the gum line due to bacterial invasion. The obvious solution was an implant, until I learned about osteonecrosis and Fosamax. Instead, I am having the root re-canalled and sealed at the exposed end with a flush filling. I would rather forego a tooth, since it is not visable nore necessary for masticatiion, than risk possible osteonecrosis due to an extraction. A solution that may be helpful to others in a similar sitution.

Better double check that, Vivian. My understanding is that Fosamax is a risk for ANY oral surgery, not just extractions - and an apicoectomy is probably more invasive than a simple extraction. Check with your physician and consider going off Fosamax for a while, extracting the tooth, and then doing something less invasive like a three unit bridge, a Maryland bridge (if possible), or a removable appliance of some kind. Don't let Fosamax fear keep you from finding out the real options.

Thanks for your comment Dr. Clifford, but I'm not having an apicoectomy, or any oral surgery. We are leaving the root in place, undisturbed in my jaw (except for redoing the root canal, which was exposed when the crown broke off). And yes, I am discontinuing Fosamax indefinately because it has provided me little improvment in my bone density in the 5 years I have been on it -- and instead given me the risk of osteonecrosis.

If you don't know, you won't take notice of it. Upto recently the case of osteonecrosis of the jaws wasn't related to bisphosphonates. Since we saw our first patients, more and more are diagnosed as such. Partly because of the above statement and partly because it takes time to develop ostesclerosis, hence necrosis, due to bisphosponates. Personally I would recommend to use parathyroid hormone agonists instead of bisphosphonates to treat osteoporosis, if the cause is not a malignant bony tumor. Unfortunately in the Netherlands they are still not fully approved for the above use by the authorities as bisphosponates still are without any comments on osteonecrosis.

Help...I was on fosamax for 10 yrs. and have been on coumadin for 35 yrs. and now need to have 2 teth extracted. i have osteopenia. my dentist insisted on giving me 4 implants so i will have more stability in my mouth. does this sound right??????

Long time fosamax user (8 years) here, off fosamax for 21/2 years. Need extensive dental restoration including several mandibular and maxillary implants. Physician wants to put me on Evista (raloxifene). What is the risk factor for raloxifene in implant surgery?

My mother just had a tooth crack, got it Xrayed and was told there was "no root, and no root canal" there. Her CTX test is 51. She's been on Fosamax weekly for a couple of years. Of course now she's off of it. The tooth was simply glued back, no surgery done. I will tell her to avoid surgery at all costs, but is there anything else she needs to do? Tests she should have? Should she rinse her mouth with hydrogen peroxide to avoid infection? Is it OK for her to travel? How long will it take for her jaw to heal?

I'm in my 60's and I have been on Fosamax for 10 years. I've also had a problem with a large space between two molars. The area has been infected for a long time. The pocket measures a 6 down from 7 after treatment and antî biotics. I've been off Fosamax for the last 4 months. I did a lab work this morning with no results yet. I also have osteoporosis. My periodontist will determine if a an osseous surgery-4+ per quad and bone replacement graft-1st site will take place if the result is above 150. Now that I've read all the posts I'm not sure I'm going to have the surgery and I'm sure not going back on Fosamax. Any advice? Thank you. Lilian Gafni

This is in response to Lilian's question. I think that you should thoroughly discuss this with your periodontist, and see if the benefits of the procedure outweigh the risks of osteonecrosis. Keep in mind, that localized areas of periodontitis with long standing infections, can in fact represent areas of incipient osteonecrosis. CTX lab test, although potentially useful in predicting the risk of osteonecrosis, is not an absolute guarantee against it.

I was perusing the comments on implants and thought it would useful for all to follow up on my comments between Jan and March 2007. The patient under discussion was on bisphosphonates and did not reveal them to me. I operated and I am very pleased to say, the case went extremely well, she is finished and to this day (May 2008)there are absolutely no problems. Perhaps we are over the hysteria of the initial scare of bisphosphonates. Thank you all for your input and support.

For those of you that have patients who have suffered as a result of BONJ; I encourage you to let them know that they may be entitled to compensation from the drug's manufacturer. I understand doctors do not like lawyers, but someone needs to fight for your injured patients. Much of this suffering could have been avoided with proper warnings, instructions and dental care. My apologies in advance for being one of those fighting for your patients.

My experience is the same as Dr. O'Roark's. I believe the other shoe may drop with some patients, but it's pretty much a "Tempest in a Tea Pot." However, let's all be careful till all the data is in. I think a dirty mouth on any drug will have treatment failures!

I am a 58 year old female who has been on Foxomax for 3 years. Three months ago I began to have a sore tooth when I bit down. I went to my dentist for an xray and it didn't show anything. She said to start using Sensidyne toothpaste and floss more. Two months later I started to have severe pain in the same tooth and couldn't chew on that side of my mouth at all. The toothache kept me awake for 2 nights until I finally went back to my dentist and she took another xray. Again the xray showed nothing. She said the tooth definitely has a problem and that I should have a root canal or extraction. My choice. But, she referred me to an oral surgeon as there is a hook on the root that could be difficult in removing. Three days after that appointment with my dentist one side of the tooth just broke off to the gum line! But, the excruciating pain had vanished once this happened. The tooth is still sore when I tap it or wiggle it or bite down on something hard. I went to see the surgeon and he wouldn't pull the tooth that day because he explained the concern of extracting a tooth and on Fosomax. He suggested put me on heavy antibiotics before the surgery and watch me very closely. I went back to my family dentist and she said it is clearly up to me, but the tooth has too much damage to even do a root canal now. The surgeon has to cut bone to get this tooth out and of course the hook on the root is not easy to remove either. What should I do? My dentist said maybe I should have the surgery while the tooth has no infection or abscess at this time and the longer I wait the better chance of this happening. I have been off the Fosomax 4 weeks now.(my choice) I'm really not sure what to do at this point, but I WILL NEVER TAKE FOSOMAX again.

The above URL has the latest guidlines and recommendations for people taking Bisphosphonates by the American Dental Association. Thanks

barbara, there are two options for you. first one is, obiviously, if the tooth becomes painful or gets infected, then you need to have that taken out even with the history of taking fosomax. An experienced and dentist who read up on literature on the topic can still manage osteomyelitis( bone infection after extraction due to osteoporosis med ). You might have to look for one who's confident to handle the situation before the surgical removal of the tooth done. Second option is, if you are too concerned about possible complication after the extraction, then have the root canal procedure done on the tooth anyway. I don't know how much tooth structure is left at this time, but once the nerve tissue gets taken out of the tooth, pain will be gone for now. Eventually, it will have to get taken out or crowned, again depending on how much tooth structure left. but having root canal treatment done on the tooth for now will be costly but at least eliminate the fear of oseomyelitis occurrence.( find a good dentist who can handle root canal tx on curved roots like you mentioned ) Current research, although not complete, suggest if you have stayed on oral bisphosphonate for about 2-3 years, chance of the osteomyelitis developing is any where between 3 to 9 % ( different % with different studies ). Usually the treatment once it develops, is administration of antibiotic and antimicrobial mouth rinse treatment( called chlorohexidine ) till the condition gets cleared up. Of course, preventing it is always a better option. Hope this helps.

Dr. Toscano gave an excellent overview on this issue in this blog a month or so ago.

Should I be concerned about taking a biophosphanate such as Fosamax if I have a history of TMJ? I am not having any current problems but I was told years ago that I do have permanent joint damage on both sides of my jaw.

I am a 53 year old female with a family history of osteoporosis. I was diagnosed with osteopenia at 44 and took Fosomax for nearly 5 years. I voluntarily stopped when I heard about the jaw necrosis after dental surgery. I still have three baby teeth - one canine, two molars that I have been nursing along well into adulthood because I did not have secondary teeth for them. My dentist is amazed and amused that these teeth have lasted so long. One of them has no root structure left. The other two are crumbling little by little and have no enamel. I have been off the Fosomax for four years now - does anyone have any knowledge of the risks of implant surgery a few years after taking Fosomax? My dentist still recommends implants and has a specialist lined up for me to see. I'm just doing some research first. What are my odds, does anyone know?

As an M.D. (internist), I'm responsible for the well-being of the whole person. In reading this site I notice much angst about bisphosphonate use, poor healing, and osteonecrosis. I feel it's important to maintain perspective on this problem. I concur that bisphosphonates like Actonel and Fosamax may be overused, but understand that up to a third of people who have a hip fracture are dead within a year of their injury. I have seen that many times in my career. Given the hundreds of thousands of Americans who fracture a hip each year, I feel it is somewhat narrow to advocate withholding important medication from people because they might one day need dental work. I'm sure osteonecrosis is miserable to work with (and even worse to have), but I am not reading about too many deaths from it in this forum. Until then, other than informing your patients about this possibility, I don't feel some of the advice refusing to treat these patients is appropriate.

IN response to Robert, MD: This is the exact problem this thread is trying to lay out for the medical community. While we can not predict when someone will need dental or oral surgery, we also can not predict if someone will fracture a hip many years down the road. The medical community continues not to understand the severity of ONJ and the morbidity this can cause. If Robert MD loses a front tooth for some reason he probably would want an implant to replace this tooth. We know that the biology of the bone is altered with impaired osteoclast function. Are we really making the bone stronger and healthier with bisphosphonates? Is seven years of clinical data with pharmaceutical smoke and mirrors what we should be basing our decisions. As a doctor I would not take this medication or allow my family to take this medication not matter what the chances of hip fracture. What happen to exercise, proper diet, calcium supplement. More attention needs to be given to the role of hormone replacement therapy. A recent seminar I attended said the fear of hormone replacement therapy was based on flawed research! The robert MD doctors out there need to get the proper denal consults and warn the patients of a seriously altered dental future as the prescribers of this medication. I have yet to see this done as a dentist with my patients. Patients are not being advised and informed by their prescribing physicians. What happened to informed consent? The medical community needs to know proper dosing protocol and proper half-life pharmocology and biology of bisphosphonates. It is shocking to see the information that was posted in 2006 by dental surgeons and dental professionals and medicine and pharmaceutical companies is continuing to push the myth of safety of bisphosphonates. There is real risk. We as dentists are begging for real respect of ONJ and what our patients are having to miss out on. Implant dentistry and advanced dental surgery is an awesome service and patients deserve to have it. Robert MD please do more research and think about the biology!!!!

Dr. Kenneth, I am aware that implant dentistry is an awesome service (I've had an implant myself), but you can't benefit from an implant if you are dead. It remains difficult for me to grasp how ONJ is a worse problem than the thousands of deaths which take place each year following osteoporotic hip fractures (some of which may be preventable). It is an oversimplification to suggest that calcium supplementation alone is the answer. Calcium is necessary, but it is not sufficient. Hormone replacement therapy may be an option, but it raises concerns about increasing the risks of breast cancer, which candidly is also a more serious problem than ONJ. I have enormous respect for my many dental friends and colleagues. I am not an adversary. I am simply suggesting that there is much more to consider in treating serious osteoporosis than how it might affect mouths. Bisphosphonates have plenty of potential problems, and I am no fan of the pharmaceutical companies, but right now these medications represent a reasonable choice, often the best choice, for many people. Respectfully, Robert P.S. In response to your exclamation points, I am very familiar with the research, and do think about the biology. Can you think of the patient as more than a jaw?

I am been highly involved with the ONJ problem since I have two patients with ONJ. I have researched many articles and books on the subject. I have enrolled one of my patients in the ONJ study with Northwest Precedent practice-based research network. There are a couple of things that I have learned. 1. ZOMETA (zolendronate) is the absolutely worst bisphosphonate you can have your patient on. If your patient is on ZOMETA, absolutely do not do an implant and be very careful of RCT work. If you have a lesion appear, do not manipulate it or do curretage. It will only make the lesion worse. 2. Bisphosphonates have a 10 year half life. Do not be prodded into waiting "3 months" and think that you can do what you will. You will get a lesion faster than you can think "lawsuit". 3. Every patient signs a two-page consent form that I have made up making them aware of the bisphosphonate problem and that any complications is at their own risk. 4. I have talked to physicians all over the country about the problem. Most of them do not know about the problem but after discussions and emails with them, they have become much more cautious to whom them prescribe these dangerous drugs. 5. I ask all of my patients to get off of their bisphosphonates and I substitute the following regimen for them. A. 3000 i.u.'s of vitamin D, B. a chewable calcium like Viactiv (the calcium carbonates and calcium citrates don't absorb well). C. if the physician wants to prescribe something, then they can prescribe EVISTA as a non-bisphosphonate. I have had very good results with that regimen. GOOD LUCK!

"How is ONJ a worse problem than the thousands of deaths which take place each year following osteoporotic hip fractures" A lot of bad assumptions here -- first, you assume that bisphosphonates can prevent hip fractures. Listen: there are no studies which demonstrate that the bisphosphonates reduce hip fractures. Nada, none. Even the FDA has issued a statement which clearly states that there are "no clear connections" between Fosamax and hip fractures. To suggest otherwise is a fraudulent and unsopportive claim. Secondly, no studies have shown a reduction in morbidity following the use of Fosamax. Nada, none. Thus your logic is failing to up the facts on hand. Third, no studies have ever compared Fosamax against more conservative measures -- weight-bearing accidents, Ca+ and Vitamin K supplements, etc. Nada, none. As far as we know the bisphosphonates are no better -- and possible worse, especially given their costs and risks -- than other nutritional and lifestyle options. These drugs are vastly overprescribed and sadly far too many people -- ignorant of the facts and swayed by the marketing campaigns to "take more drugs" -- will be harmed by these agents. (some of which may be preventable).

As an Internist, I have read these posts with great interest, I have a patient with possible osteonecrosis who has never taken IV bisphosphonates,but took oral fosamax. I think it is a terrible complication to happen to anybody but let's also understand why these patients are taking these drugs in the first place,osteoporotic fractures can be debilitating and very painful and cause significant morbidity,I agree that the entire treatment algorithm for osteoporosis needs to be revised in light of this information,I believe that stopping these drugs for a few weeks or months prior to any dental procedures is useless, the half life of these drugs is measured in years not days or weeks. The damage is unfortunately already done.I would submit that any elective dental procedures on a patient taking these drugs be avoided altogether until we have more information.

Good points made.

I'm looking over this topic for a patient. I presently have a pt on Zometa(Stage iv prostate CA with secondary bone sites) who had a small tissue break in the retromylohyoid area