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Medical Forum / General / Dentistry / December 2006Bisphosphonates
Anyone have any horror stories about the ubiquitous oral bisphosphonates (Boniva, Fosamax)causing osteonecrosis of the jaw as a result of perio surg, implants, or extraction? > Anyone have any horror stories about the ubiquitous oral bisphosphonates > (Boniva, Fosamax)causing osteonecrosis of the jaw as a result of perio > surg, implants, or extraction? There are scattered reports, and they're bound to become more numerous over time. Still, considering the number of people on these drugs the numbers of ONJ that can be linked to oral bisphosphonates is small. This of course is not true of injectible bisphosphonates. However, since most patients receiving these drugs have significant illness being treated and the risk of pathologic fracture as a result is high (and the morbidity associated with these pathologic fractures is significant) the relatively higher risks associated with the injectibles is justifiable. Steve It is a big problem. Basically patients that have been taking bisphosphonates are at risk of jaw necrosis and there is not much that can be done for them. The treatment for jaw necrosis involves major surgery prosthetics and disfigurement as a result and there is no way to prevent this. Anything from a simple extraction or root canal or dental implant can cause this in the wrong patient. We are told to tell patients to discuss these risks vs benefits with their physician who is prescribing these meds. In my opinion these meds are too dangerious and should not be precribed. I can forsee a class action starting against these companies that are releasing these pills. We will be seeing more cases of jaw necrosis as a result. I also believe the FDA is at fault for giving clearance to these pills. The warning label is enough to discourage anyone from taking these meds. Obviously osteoporosis patients benefit from these drugs but should they develop a tooth ache, decay needing a root canal, an injury to their teeth and jaw requiring cosmetic repair, they are out of luck and may have been in a better situation if they did not take these pills. > > Anyone have any horror stories about the ubiquitous oral bisphosphonates > > (Boniva, Fosamax)causing osteonecrosis of the jaw as a result of perio [quoted text clipped - 10 lines] > > Steve > It is a big problem. Basically patients that have been taking > bisphosphonates are at risk of jaw necrosis and there is not much that [quoted text clipped - 13 lines] > their teeth and jaw requiring cosmetic repair, they are out of luck and > may have been in a better situation if they did not take these pills. It is always difficult to do a seat-of-the-pants risk/benefit analysis when the risk takes years to fully evaluate. Surely fractured hips in the elderly are a major health risk. The concensus is that this is still a small risk with oral bisphosphonates. We need to keep an eye on the statistics though. I asked a urologist who put a relative of mine on IV Zometa whether he'd seen cases of ONJ. Of course he did not--who even knows how often the prescribing urologist/oncologist etc. will see the results of their medications? By the same token, I cannot in good conscience scare patients off bisphosphonates when I cannot evaluate or see the morbitity associated with osteoporosis. This is a difficult issue, and we all do the best we can. And then the lawyers come in and make those fine judgements for us. Steve >>> Anyone have any horror stories about the ubiquitous oral bisphosphonates >>> (Boniva, Fosamax)causing osteonecrosis of the jaw as a result of perio [quoted text clipped - 10 lines] >> >> Steve I have not heard anyone actually die from a broken hip but maybe this can happen. Although I understand things tend to go down hill once a patient breaks his/her hip. I know that we can replace hips with implants and there are always new technologies coming out. I would also suspect that if bisphosphonates cause necrosis of the jaw, who is to say one can not get necrosis of the hip after a fracture and bisphosphonate use. Using bisphosphonates does not guarantee that one can not still get fractures or that this is a cure for osteoporosis, they just say bisphosphonates help. I would much rather the medical research community focused on other options then to set patients up for other problems. These drugs have so many adverse side effects and risks including kidney cancer, that I do not even see why anyone would bother with these drugs. The theraputic effects are not spontanious yet the risks of adverse effects and jaw necrosis are. > > It is a big problem. Basically patients that have been taking > > bisphosphonates are at risk of jaw necrosis and there is not much that [quoted text clipped - 44 lines] > >> > >> Steve > I have not heard anyone actually die from a broken hip but maybe this > can happen. Although I understand things tend to go down hill once a [quoted text clipped - 11 lines] > with these drugs. The theraputic effects are not spontanious yet the > risks of adverse effects and jaw necrosis are. AFAIK, all pharmaceuticals have adverse reactions. Some are more serious than others. Certainly ONJ risk needs to be reevaluated as more people are on these drugs, and I agree that it would be great if there were other effective treatments for osteoporosis (even more true for osteolytic metastatic cancer)without the ONJ risk, but we have what we have. What we can hope for is an atmosphere where information is transmitted freely between those who prescribe the drugs and those who see the sequellae. I assume pharmaceutical companies are working on other approaches, but it's likely that there is no risk-free approach that will be effective. I can only hope that honest medical researchers and clinicians are the ones dictating treatment protocols--and not attorneys. Steve  SignatureMark & Steven Bornfeld DDS http://www.dentaltwins.com Brooklyn, NY 718-258-5001 >> I have not heard anyone actually die from a broken hip but maybe this >> can happen. Although I understand things tend to go down hill once a [quoted text clipped - 27 lines] > > Steve BTW, here is a survey article of morbidity/mortality associated with hip fracture, (included are statistics for effectiveness of bisphosphonates for lowering fracture risks) http://www.postgradmed.com/issues/2003/09_03/1fiechtner.htm Steve SignatureMark & Steven Bornfeld DDS http://www.dentaltwins.com Brooklyn, NY 718-258-5001 > I have not heard anyone actually die from a broken hip but maybe this > can happen. Although I understand things tend to go down hill once a > patient breaks his/her hip. Yes, true. They die from complications of immobility. Pneumonia is the biggest problem, but also decubiti (bed sores), constipation, loss of appetite, urinary tract infections from stasis, depression, lowered immunity leading to infections, mental confusion from pain medication and/or multiple medications. Without rapid intervention and constant support, it is a downward spiral for the elderly. They are more fragile and often have other chronic conditions. Once they lose their independence or feel they have become a burden to their family some just "give up" and die. I'm an RN and have seen this happen many times. It seems to me that the necrotic jaw is much more rare than deaths related to hip fractures. >> I have not heard anyone actually die from a broken hip but maybe this >> can happen. Although I understand things tend to go down hill once a [quoted text clipped - 11 lines] > It seems to me that the necrotic jaw is much more rare than deaths > related to hip fractures. Your comments on the morbidity associated with fractured hips is well taken. Remember though, that the problem of ONJ is a relatively new one, and from what I've heard it is rapidly growing, so the need to re-evaluate this risk continually is there. Again, this still seems to be a far bigger problem with the injectable bisphosphonates, where the nature of the patients' problems makes the risk of ONJ more acceptable given the alternatives. But ONJ in these cases is not rare, and it is a condition with a significant morbidity itself, an no--that's ZERO--effective treatment at this time. Steve But ONJ in these cases is not rare, and it is a > condition with a significant morbidity itself, an no--that's > ZERO--effective treatment at this time. > > Steve Hi Steve, I appreciate your response. Yes, I agree that ONJ has a significant morbidity with no cure at this time. We surely don't have the full picture yet. Still, I try to stay current with women's health issues. Just so you know from where I get my information, here is what I am being told in the current issue of my Harvard Women's Health Newsletter: Since we last wrote about this problem, more cases of osteonecrosis have been reported. Most have occurred among cancer patients taking intravenous bisphosphonates, but a handful have involved otherwise healthy women taking oral forms of these drugs for osteoporosis prevention or treatment... ...Compared to the millions of women taking bisphosphonates, the number of osteonecrosis cases is still negligible. The American Dental Association estimates the prevalence to be only about 0.7 cases per 100,000 person years. That translates to 7 cases per year for every one million people taking oral bisphosphonates. The risk is mostly among cancer patients taking zoledronate or pamidronate. To further investigate the extent of the problem among otherwise healthy women taking bisphosphonates, researchers at the Harvard School of Dental Medicine are examining medical insurance claims for jaw surgery. Also, the National Institute of Dental Research plans to study the development of the condition in bisphosphonate-takers... Hummy > But ONJ in these cases is not rare, and it is a >> condition with a significant morbidity itself, an no--that's [quoted text clipped - 28 lines] > > Hummy There have been a number of studies, and as you say the numbers of ONJ cases among ORAL bisphosphonate users is still relatively very low. The percentage of ONJ cases among zoledronate and pamidronate patients (mainly cancer patients) seems to be climbing in the more recent studies cited at a recent lecture I attended--as high as 10% of patients taking these medications over one year. Just two comments--I would be careful about using the concept of "cases/person-years", since the risk of ONJ at least in the IV drugs seems to increase with the duration of use. Therefore as there are more patients having been on these meds for longer durations, we should not be surprised to see the relative incidence of ONJ rise. Secondly, I wonder about the rationale for Harvard examining claims for jaw surgery, since current thinking recommends conservative treatment. While management is likely to be accomplished by OMF surgeons, this seems a really inefficient way of determining true incidence (though it does seem to imply a recognition that doctors prescribing bisphosphonates are likely never to become aware of ONJ incidence). Steve I would think it would be prudent for patients who are being put on these medications to at the very least take cake of all their dental problem and be clear of any dental complicaions as a result of dental treatment for a period of at the very least 2 years before initiating these meds. Because once they start these meds and another dental problem arises they automatically become part of the statistics. > But ONJ in these cases is not rare, and it is a > > condition with a significant morbidity itself, an no--that's [quoted text clipped - 28 lines] > > Hummy > I would think it would be prudent for patients who are being put on > these medications to at the very least take cake of all their dental > problem and be clear of any dental complicaions as a result of dental > treatment for a period of at the very least 2 years before initiating > these meds. Because once they start these meds and another dental > problem arises they automatically become part of the statistics. Maybe. But at the very least, oncologists and urologists who wish to put their patients on IV bisphosphonates should inform their patients of the very real risk and find out if they are current with their dental care. Full disclosure: my dad has stage IV prostate ca with bony metastasis. His urologist decided to put him on Zometa, and not a word about risk of dental treatment. I told him I was a dentist, and whether it might be possible to delay starting the Zometa while I dragged my dad into the office for the first time in a couple of years. My dad needed two extractions and one root canal. Naturally I was not happy, and resisted the urge to tapdance on the urologist's head. I asked if he was aware of the problem, and he said he'd "never seen a case" of ONJ. Well, hopefully I edjakated him. Steve >>But ONJ in these cases is not rare, and it is a >> [quoted text clipped - 29 lines] >> >>Hummy SignatureMark & Steven Bornfeld DDS http://www.dentaltwins.com Brooklyn, NY 718-258-5001 well that's fine for patients with current dental problems but what about if there is future dental trauma due to injury? What then??? > > I would think it would be prudent for patients who are being put on > > these medications to at the very least take cake of all their dental [quoted text clipped - 57 lines] > Brooklyn, NY > 718-258-5001 > well that's fine for patients with current dental problems but what > about if there is future dental trauma due to injury? What then??? Alex-- Whatever I say today may be worthless tomorrow. Cox-2 inhibitors were the biggest thing since sliced bread; now they ain't. We always have to make the best decisions we can based on the available evidence. Most important is that we don't operate in a professional vacuum--we know why the patients are being medicated; other professionals know our concerns, and we try to work out the best overall assessment of risk and benefit to the patient--and hopefully bring the patient into the decision-making process--since whatever clinical decisions we make develop the risks they must accept. Steve >>> I would think it would be prudent for patients who are being put on >>> these medications to at the very least take cake of all their dental [quoted text clipped - 56 lines] >> Brooklyn, NY >> 718-258-5001 I understand what you are saying. But for me it does not make sense to give something to patients thats treats one problem while creating another. It's different if we had no proof or knows cases of adverse effects, but in the case of bisphosphonates we do. I suppose patients undergoing cancer treatment an are fighting for their life, what's a risk of jaw necrosis to them?? I'm sure it is further from their mind. Heck the chemo alone is toxifying to their system. However there are many patients right now that are taking these meds for prophylactic reasons not knowing the risks. I certainly think we need to find alternative treatment for cancer patients and those taking the meds for prevention with the emphasis and urgency on the former. Apparently this is how we treat people in this part of the world we exchange one problem for another and get them hooked on pills and surgery as the answer to everything. (will that be paper or plastic...brand name or generic) > > well that's fine for patients with current dental problems but what > > about if there is future dental trauma due to injury? What then??? [quoted text clipped - 73 lines] > >> Brooklyn, NY > >> 718-258-5001 > I understand what you are saying. But for me it does not make sense to > give something to patients thats treats one problem while creating [quoted text clipped - 11 lines] > answer to everything. (will that be paper or plastic...brand name or > generic) There is a lot of truth to what you say, and the conventional wisdom DOES change over time--it doubtless will here too. Just one recent example off the top of my head--HRT for menopausal symptoms. Best, Steve >>> well that's fine for patients with current dental problems but what >>> about if there is future dental trauma due to injury? What then??? [quoted text clipped - 71 lines] >>>> Brooklyn, NY >>>> 718-258-5001 I admit to a person interest in this topic. In fact, I posted about this very topic back in March of this year. I lost both of my jaw joints (TMJ) to osteonecrosis which was one of many unfortunate complications resulting from orthognathic surgery (mandibular advancement to protect me from developing jaw joint pain) in 1983. People with a long history in smd are likely familiar with "my story". Back in 2000, I underwent dental care under general anesthesia in the OR of UCLA. (This was necessary because of my very limited jaw opening.) The pre-admission workup revealed that I had significant osteoporosis and the internal medicine doctor was more than eager to immediately place me on both hormone therapy *and* Fosamax. I was concerned about what impact the osteoporosis might have had upon the jaw bone because one of the difficulties of the dental surgery and dental restorative work was the fact that overextending the opening of my jaw under general anesthesia could result in the two artificial jaw joints (TMJ) literally popping off the bone; fracturing the jaw and destroying my prosthetic-situation. Anyway, long story short, I said "no" to the Fosamax simply because at that time, there was only seven years experience with the drug. It was going to be prescribed as a drug I would take for the rest of my life. I was not willing to take the risk about such a new drug. On the other hand, I was willing to accept that I had a "high risk of fracture" according to my bone density studies (and I still do). On the balance scale, there was "the risk of the unknown" on both sides of the scale. I decided to stick with not rocking the boat. And! Am I ever glad that I made the decision not to take that drug. I can't imagine today, a good six years after that event, why there hasn't been more concern about this among people who have serious conditions related to "the surgical TMJ". Should I one day find myself needing this family of drugs for the treatment of a cancer, I am very willing to admit that I would not be able to make a decision to be aggressive towards the cancer. The thought of more osteonecrosis of the jaw is absolutely terrifying to me. The one thing I see at this point, is another unfortunate chapter in the book titled, "The TMJ Iatroepidemic". Webby > I understand what you are saying. But for me it does not make sense to > give something to patients thats treats one problem while creating [quoted text clipped - 92 lines] > > >> Brooklyn, NY > > >> 718-258-5001 aaa >But ONJ in these cases is not rare, and it is a >condition with a significant morbidity itself, an no--that's >ZERO--effective treatment at this time. > >Steve OK I give. Osteo Necrosis J...? OsteoNecroticJaw ? >>But ONJ in these cases is not rare, and it is a >>condition with a significant morbidity itself, an no--that's [quoted text clipped - 7 lines] > > OsteoNecroticJaw ? Bingo--osteonecrosis of the jaw. Sorry to be obscure. There are frequent lively discussions of this issue on the bulletin board of oral pathology http://www.sdm.buffalo.edu/bbop/ ...and one of my bugaboos is the abbreviations used with the presumption that we all know what they're talking about. Sorry to have fallen prey to this same practice. Steve SignatureMark & Steven Bornfeld DDS http://www.dentaltwins.com Brooklyn, NY 718-258-5001 >>>But ONJ in these cases is not rare, and it is a >>>condition with a significant morbidity itself, an no--that's [quoted text clipped - 19 lines] > >Steve Not a problem bro. Wouldn't ONMandibularis or ONMaxillarus be more accurate ? Thanks for the link BTW. > Anyone have any horror stories about the ubiquitous oral bisphosphonates > (Boniva, Fosamax)causing osteonecrosis of the jaw as a result of perio > surg, implants, or extraction? I have been researching this on the web and have found plenty of reassuring statistics such as "Less than 1 chance in 100000", etc. However, that does not seem to be the correct question and answer. What I think needs to be identified is, for a given population of Fosamax users who have tooth extractions, implants, or other invasive dental procedures, what percentage experiences ONJ? So: 1. Among those of you who are on therapy now, who among you have had extractions, implants, etc? 2. For those of you are dentists and oral health professionals, have you performedthese operations on patients who are on oral fosamax therapy, and what sorts of results have you seen? Thanks for any replies. Just me >> Anyone have any horror stories about the ubiquitous oral bisphosphonates >> (Boniva, Fosamax)causing osteonecrosis of the jaw as a result of perio [quoted text clipped - 21 lines] > > Just me The numbers are too low to draw any conclusions. Also, the tendency to promote ONJ clearly increases over time, so the statistics are bound to get worse. That doesn't mean they'll get bad, but...putting a number on it now probably isn't as useful as it will be in maybe 10 years (if the drugs are still in use). Steve > >> Anyone have any horror stories about the ubiquitous oral bisphosphonates > >> (Boniva, Fosamax)causing osteonecrosis of the jaw as a result of perio [quoted text clipped - 29 lines] > > Steve Hello Steve and us, I'm thinking about how to share what I am thinking. After several deletes, I am left with simply posting to the group that I *do* have something more to contribute but I don't want to open a pandora's box over it. All in all, what I think is this: people who have the most to lose are probably the people who have already lost too much and they are not likely to be getting adequate warning. In my own case, I don't have *anything* left that I can afford to gamble with when it comes to risking what I have left of my jaw bones and jaw function. I think that the maxillofacial surgeons should have (or get) an opinion, as a group, as to what this risk of ONJ means to people who have existing pathology of the TMJs, especially as a result of defective joint implant materials, and the jaw as a whole. For the people, especially women because they represent the majority of TMJ surgical patients during the 1980s, who are approaching or at the age of menopause or who have been post menopausal for some time now, osteoporosis is an issue with a special twist for some of "us". I don't want to belabor this subject with the group but I will gladly contribure *from my POV* if there is an interest. This subject is ever so important to what is a (presumed) rare population of people. And just because a given patient-population is rare (less than 250,000 in the USA), this should not mean that their needs are not important. It's a bit frustrating to bite my tongue and type at the same time. If I go so far as to tie my fingers up, it's especially frustrating because I'm left without having fully expressed my thoughts as a patient with special needs on this important subject. Webby > Hello Steve and us, > [quoted text clipped - 30 lines] > > Webby Hi Sabra-- I'm not an expert here. I have heard reports of SPONTANEOUS ONJ, but I'm not sure I've heard it after oral bisphosphonate use. In any case, the majority of cases still involve trauma to the tissues after bisphosphonate use has started (and more likely the longer bisphosphonates have been used). While it is possible that some of these cases have involved the TMJ apparatus itself, I don't recall ever hearing of one. They are primarily post extraction/post surgical, or if not precipitated by surgery they tend to be under the bearing areas of dentures. Naturally we have to be aware, and revise our expectations as more data become available. Of course the suspicion is that this is another Merck/Vioxx scenario, that the phama companies withheld information. But I have no evidence to support it, and some of the companies (Novartis, for example) sent out warning notices to all doctors not really early, but not really late either, and I see no evidence of stonewalling on the issue. The main problem esp. with the oral bisphosphonates is that this is a pretty late complication, so it's understandable that it would have taken a while to become aware of the problems. Steve SignatureMark & Steven Bornfeld DDS http://www.dentaltwins.com Brooklyn, NY 718-258-5001 > > Hello Steve and us, > > [quoted text clipped - 54 lines] > > Steve Good to hear from you, Steve. I don't have any suspicion about information being withheld. I don't think that applies in this case. Thanks for sharing your thoughts! Sabra/Webby Another problem is there are still many dentists and md's in practice who are not even aware of the risks of doing surgical procedures on patients who are taking bisphosphonates. The FDA or state boards have not even made an effort to contact health care professionals. I found out about this problem through word of mouth then had to do my own research. Later we saw articles on this from the dental associations however solutions as to how to proceed weren't clear until very recently. > > Anyone have any horror stories about the ubiquitous oral bisphosphonates > > (Boniva, Fosamax)causing osteonecrosis of the jaw as a result of perio [quoted text clipped - 21 lines] > > Just me I brought the subject to smd on March 22, 2005. The thread is available for review on Google groups for anyone interested. I am reposting my old post. From: The Webby - view profile Date: Tues, Mar 22 2005 4:00 pm Email: The Webby <nospamattmjiatroepidemicnos...@san.rr.com> Groups: sci.med.dentistry, alt.support.jaw-disorders Not yet rated Rating: show options Reply | Reply to Author | Forward | Print | Individual Message | Show original | Report Abuse | Find messages by this author http://www.niams.nih.gov/hi/topics/avascular_necrosis/ In my case, it was (later) determined that I suffered bilateral avascular necrosis of the temporomandibular joints as a result of surgical complications from surgical error (orthognathic surgery). The joints were destroyed and thus began the saga of my chronic and permanent TMJ disability and disease. If you search Google Groups for "osteonecrosis jaw" you'll discover posts that you may not have paid attention to in the past -- or maybe it was even *you* who put the posts up! Either way, it's an interesting review. The subjects of TMJ avascular necrosis and osteonecrosis of the maxillofacial area (jaw/jawbone) are or should be matters of interest to dental related newsgroups. II'm just tossing these topics out to see if there's any interest in getting a discussion going. Turn on your television and count how many times you see an advertisement for Fosamax (alendronate) in one evening. I watch relatively little television but I sure see a lot of Fosamax pushing. Webby _______________ > Another problem is there are still many dentists and md's in practice > who are not even aware of the risks of doing surgical procedures on [quoted text clipped - 31 lines] > > > > Just me > I brought the subject to smd on March 22, 2005. The thread is available > for review on Google groups for anyone interested. I am reposting my [quoted text clipped - 71 lines] > > > > > > Just me I think the risks should be clearly stated on the prescription and warnings should be made clear to the patient by the physicians that prescribe Fosamax (or other biphosphonates) and by the pharmacists that dispense these. However even young patients (under age 60) can be confined to wheelchair because their spines have literally collapsed due to osteoporosis! So as always, one must weigh the risk versus benefit. There is rarely if ever any perfect medication or medical procedure that comes entirely without risk. Medicine is not a perfect science, by any means. jmho -Sue > > I brought the subject to smd on March 22, 2005. The thread is available > > for review on Google groups for anyone interested. I am reposting my [quoted text clipped - 90 lines] > jmho > -Sue An elderly relative of mine was put on Fosamax in early 2005. She has had ongoing dental issues for years; she's one of those people who just wants to hold onto every tooth she can (for life) no matter how much dentistry is involved and no matter how much trouble the dentistry causes her. But at 90 years of age, it seems that putting such a person on Fosamax, given what is and isn't known about potential complications related to ONJ, is tipping the scale a bit. After some family discussions, she told her doctor she didn't want to take "the bone medicine". She didn't really know why but she deferred to family advice. Some might say that she should have taken her doctor's advice over that of the family. For all the dentistry she has had done since then, we sleep better knowing that the Fosamax isn't going to add misery to misery. Webby > > > I brought the subject to smd on March 22, 2005. The thread is available > > > for review on Google groups for anyone interested. I am reposting my [quoted text clipped - 107 lines] > > Webby >From what I understand, the majority of ONJ cases (with biphosphonates) occur in cancer patients that are receiving large doses IV. The risk for those taking oral Fosamax is considered low, but is admittedly UNKNOWN. Another risk factor for ONJ is tooth extraction. If patients are on biphosphonates for any reason, they should avoid tooth extraction and should receive RCT instead (according to what I have read). I have read summaries of the large clinical study that led to its approval (Fosamax) and the larger trial did not include anyone over 79. In addition I think I read elsewhere (re: a separate study) that there was no benefit found in the very elderly as far as hip fracture goes.... so in the case of your relative you may have gave her some very good advice (imho). IMPORTANT DISCLAIMER: Do not quote me on this information. I read this a long time ago and am going on memory which is often faulty. I will look for the references and post them for others to view and interpret. Also I apologize if I am repeating anything that has already been said on this thread, I have not read the entire thread. Sue > > > > I brought the subject to smd on March 22, 2005. The thread is available > > > > for review on Google groups for anyone interested. I am reposting my [quoted text clipped - 128 lines] > Also I apologize if I am repeating anything that has already been said > on this thread, I have not read the entire thread. *Corrections: I went back and checked the clinical trial references. I wrote: "I have read summaries of the large clinical study that led to its approval (Fosamax) and the larger trial did not include anyone over 79. " Correction: The safety and efficacy trials for Fosamax (Alendronate) were called FIT (Fracture Intervention Trial) and FOSIT (Fosamax International Trial). FIT included 6459 postmenopausal women age 55-81, with prior vertebral fracture and reduced femural neck bone density score (<2.0). FOSIT included 1908 women (from 34 different countries), mean age 63 years. I wrote: "In addition I think I read elsewhere (re: a separate study) that there was no benefit found in the very elderly as far as hip fracture goes...." Correction: I was mistakenly thinking about Risedronate (a different biphosphonate sold as Actonel), not Alendronate (which is Fosamax). The safety and efficacy trials for Actonel included: VERT-MN (vertebral efficacy with risedronate therapy, Multi-National) and VERT-US (vertebral efficacy with risedronate therapy, United States). Unlike the Fosamax trials, these trials inlcuded postmenopausal women with OR without signs or symptoms of osteoporasis. **These were then followed up by an additional trial called HIP, the study that I was thinking about. The HIP trial studied Risedronate and its effect on hip fracture, and compared women ages(>70-79 yrs) versus women (>=80 yrs). I must clarify the results. The results showed a decrease in hip fracture for both groups on Risedronate but in the women over 80 yrs, only women that had osteoporosis showed a reduction in hip fractures. Bottomline:There are few data on osteoporosis treatment in women older than 85. I hope this makes sense. -Sue Here are some references for anyone intersested They are all mixed up. I did not have time to put these all together in order): http://content.nejm.org/cgi/content/abstract/344/5/333 http://content.nejm.org/cgi/content/abstract/344/5/333 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi? cmd=retrieve&db=pubmed&list_uids=8950879&dopt=medline http://www.medscape.com/viewarticle/410801_2 http://www.ahrq.gov/clinic/3rduspstf/osteoporosis/osteorr.htm http://www.medscape.com/viewarticle/410801_2 http://www.medscape.com/viewarticle/522830_44 http://japan.medscape.com/viewarticle/547486_1 > > > > > I brought the subject to smd on March 22, 2005. The thread is available > > > > > for review on Google groups for anyone interested. I am reposting my [quoted text clipped - 194 lines] > > http://japan.medscape.com/viewarticle/547486_1 SORRY. I HAVE FURTHER CORRECTIONS. I wrote: > The safety and efficacy trials for Actonel included: VERT-MN (vertebral > efficacy with risedronate therapy, Multi-National) and VERT-US > (vertebral efficacy with risedronate therapy, United States). Unlike > the Fosamax trials, these trials inlcuded postmenopausal women with OR > without signs or symptoms of osteoporasis. Correction. WRONG AGAIN. The trials were: "To determine the effect of risedronate on vertebral fracture in high-risk subjects, we pooled data from two randomized, double-blind studies [Vertebral Efficacy with Risedronate Therapy (VERT) Multinational (VERT-MN) and VERT-North America (VERT-NA)] in 3684 postmenopausal osteoporotic women treated with placebo or risedronate 2.5 or 5 mg/d and analyzed fracture risk in subgroups of subjects at high risk for fracture due to greater age or more prevalent fractures (vs. median for overall study population), or lower bone mineral density (T-score, -2.5 or less)." NOTE ALSO: The women on study DID have signs of osteoporosis, so I mistated this as well. Sorry. I will take more time to make sure I have everything correct before I write again. -Sue >>>>>>I brought the subject to smd on March 22, 2005. The thread is available >>>>>>for review on Google groups for anyone interested. I am reposting my [quoted text clipped - 223 lines] > before I write again. > -Sue Thanks for all this. Steve SignatureMark & Steven Bornfeld DDS http://www.dentaltwins.com Brooklyn, NY 718-258-5001 > >>>>>>I brought the subject to smd on March 22, 2005. The thread is available > >>>>>>for review on Google groups for anyone interested. I am reposting my [quoted text clipped - 227 lines] > > Steve Ditto. Webby > > > > > > I brought the subject to smd on March 22, 2005. The thread is available > > > > > > for review on Google groups for anyone interested. I am reposting my [quoted text clipped - 223 lines] > before I write again. > -Sue You are welcome! It is all very confusing to me (all of the various studies), but I guess the only point I was trying to make is that there are few data on osteoporosis drug treatment (biphosphonates) in women over 85 yr-old, and my guess is even fewer data on men of all ages. Therefore currently, the potential benefits are virtually unknown for these groups...(imho). I really just stopped in to wish you all HAPPY HOLIDAYS. I hope the new year brings a revival of the long-time friendships that had been developed here over some years of conversation on SMD! Sincerely, Sue > Another problem is there are still many dentists and md's in practice > who are not even aware of the risks of doing surgical procedures on [quoted text clipped - 5 lines] > Later we saw articles on this from the dental associations however > solutions as to how to proceed weren't clear until very recently. Well, IMO they're still far from clear. :-/. I used to get an FDA newsletter with reports of adverse reactions--they either stopped mailing them or I got off the mailing list. I did receive a mailing from Novartis a couple of years ago. I have no idea how many docs are unaware of the problem at this late date (I don't doubt that there are some), but the bigger problem is the patient who doesn't note it in the medical history. Steve >>>Anyone have any horror stories about the ubiquitous oral bisphosphonates >>>(Boniva, Fosamax)causing osteonecrosis of the jaw as a result of perio [quoted text clipped - 21 lines] >> >>Just me SignatureMark & Steven Bornfeld DDS http://www.dentaltwins.com Brooklyn, NY 718-258-5001 |
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