"The trouble with bisphosphonates"

Hi Chris, you raise an interesting question re: how success rate is calculated. Math isn't my forte, but since I don't see how there's really any way to know whether or not a fracture that might or might not have occurred actually has or hasn't been prevented, it certainly stands to reason that the calculation is skewed in that way.

I think at the least you have to have suspicions if so many are put on it with such low risk of fractures.  It seems to have it's place for those who are definitely at higher risk (just as statins do for men who have already had a heart attack) but for those at lower risk it at least warrants a discussion with a doctor before accepting a prescription, I'd have thought.

Kathleen, I looked for the actual article but could find only the audio. I think it may have appeared in a medical journal (BMJ?) and like so many med-journal articles is accessible to the public only through a very pricey subscription. That is very interesting re: the woman who took Fosamax for eight years to no avail. I, too, as I've mentioned in previous posts, have been told I "need" a bisphosphonate if I "want" to avoid fracture. A major dilemma that I see is that the bisphosphonates have now officially been labeled, in U.S. by FDA, as risky to take beyond two or at most three years. However, my reading is not finding that whatever gains might or might not be made with bisphosphonates are maintained indefinitely. Therefore, patients may be told they can take a brief "drug holiday," then told that if they "want" to maintain the benefits they "need" to resume another osteo med ... probably a bisphosphonate. So in reality the warning about stopping the drugs after a few years is "unenforceable," as it puts patients in a Catch-22 situation.

 

I don't really understand this aspect because isn't it supposed to have a half life of 10 years?  Or is that just for the side effects and not for the benefits?

I'm confused by that aspect of it as well; however, I've read both, i.e., that benefits do not continue indefinitely or even necessarily for long before one is no longer taking them and also that the side effects can persist for many years. That said, two of the most concerning side effects, ONJ and atypical femoral fracture, wouldn't fit into a persisting-for-years category: ONJ is often described as "untreatable," while atypical fracture would presumably heal in time, though during that period one would run all of the usual risks of a fracture, e.g., infection and other complications.

I have an appointment with my endocrinologist in a couple of weeks and will see if he can shed any light on this, though he is a big fan of the osteo meds so not sure if whatever he says can be considered unbiased.

 

Do let us know what they say about this, even though they may be biased:-)  Hope your appointment goes well though:-)

Juno, you didn't annoy me because I can absolutely see your thinking on it.  Regarding the risk of fractures through falls because of age, I just wonder if people at risk were offered some sort of exercise classes that included strengthening muscles and improving balance, this could really produce results.  We decided to rebel against getting older here and bought an exercise bike, a treadmill and have ordered a cross trainer (that's a machine, not an angry person:-) ) and having used the bike for about a month now and the treadmill for a couple of weeks, our fitness has increased in leaps and bounds.  We 'work out together' every morning.  It's improved cardiac fitness, as well as stronger muscles, and we both feel so much better.  So maybe we can put off the danger of falls!  I'm limited on the treadmill because of knee arthritis, but still feeling the benefit of what I can do!  I do wonder if sometimes (not always!) osteoporosis can be linked to lack of activity, if weight bearing exercise can improve it, but that's a question rather than a statement.  But if there is a link, then could there be a link to fractures because muscles and balance have suffered?  But I stress, this IS a question, not a statement.

Hi Chris, I think you're spot-on re. trying to prevent falls. It seems that even small regular walking, dancing and, above all, Tai Chi - which is suitable from age 10 to 100. Really gentle and effective (though I haven't tried it yet). I'm not aware that lack of exercise could cause OP, but once you have it, you HAVE to keep moving.  . . Re. whether weight-bearing exerise can improve OP, I THINK  there is an established very small improvement in bone density with regular exercise of this kind. . . .  J

Yes Juno!  We do Tai Chi too!  It was actually Tai Chi that got us feeling fit enough to venture on to more physical exercise.  Tai Chi is particularly good for balance, as well as keeping core muscles strong.  This is where I think it's such a poor show when a GP hands out Alendronic Acid, as they did in my case, when I didn't even qualify for it, and there was no mention of diet or supplements or exercise or anything.  I SO hope more and more people will google it and come across groups like this one, so they can help themselves!

I'm delighted to hear about your Tai Chi. I really must think about it also. J

Honestly Juno, we were gobsmacked the difference it made just doing it for about 10 minutes a day within two weeks!  I started losing weight and we both felt SO much better.  We got the Tai Chi for arthritis by Paul Lam, and you can even do that sitting down if you need to.  But we were both so out of condition, and I struggled to do the warm up initially LOL!  Hope it goes well for you too!

Thank you for all that. J

Hi Juno, I can find little fault with your excellent summary of takeaway points i. The one you neglected to mention is that the ratio of "number needed to treat" to "number of fractures prevented" is unfavorable.

I would quibble, though, with the statement that  " 'severe' OP ... could be dangerous to leave untreated." Not because severe OP poses no fracture risk -- I doubt any right-minded person would claim that -- but because the degree of efficacy of the osteo meds for ANY subset of OP patients is in serious contention (see "number needed to treat" above). 

I don't feel happy with the "wait and see" approach, either. I would much rather there was a treatment option that seemed likely to be effective and that didn't pose the risk of catastrophic, perhaps irreversible side effects. Unless and until such an option is available, however, I see no choice but to "wait and see," as unsettling as that feels.

 

A very balanced view too Allison.  I think anyone new to the diagnosis of Osteoporosis and not understanding about treatments will get so much useful information from these discussions!  I just wish GP's would have this discussion and send patients off to think about it before doling out prescriptions that may be totally unnecessary and taking a huge risk with little chance of usefulness.

My GP did send me away to see the dentist and to think about taking any of the meds. 

Last visit she did tell me none of her patients had had adverse effects from taking the drugs.

I will test each year to keep a check on the t scores.

Kathleen, you are one lucky lady to have a GP like that!  Hang on to them for dear life!

I know. She is caring and thorough and actually empathises with you. 

She is English but has been Australia for quite a few years.

Allison, remind me again what your t scores are?

Well you are very lucky.  Wish they'd send my lot to Australia LOL!

Score for spine, -3.0 (osteoporosis); for hip, -1.6 (osteopenia).

Yes, I didn't mention the 'number to treat " issue. To be honest  I have a  bit of trouble with the concept. Does it mean that, eg., you may have to treat 100 patients before you prevent, say, 5 fractures in some of these people?  If so, is this the case for ANY osteoporosis medication - Prolia, Forteo, Strontuim, as welll as the dreaded bisphosphonates???   Have they broken down results in this way at all?  Regards,  J

That does not sound too bad then especially the hips! My hips t score is fairly low like that too. The back is the concern as my L4 is -4.3 but overall reading for the back is -3.4.

I will check mine annually even if I have to pay sometimes.

 

Yes, I think your guess as to what number to treat signifies is correct. I don't know if that concept applies to the non-bisphosphonate osteo meds you listed. Forteo, per one of our earlier exchanges on this site, isn't approved past two years of use in the U.S. due to the heightened cancer risk over time. I don't think that strontium is approved as an osteo med in the U.S.; per Save Our Bones, a site of an articulate critic of osteo meds, strontium's side effects include nausea, skin irritation, blood clots, fainting, interference with calcium absorption, and reduction in tensile strength leading to risk of fracture. Prolia's side-effect profile: low calcium levels; serious skin, lower abdomen, bladder, or ear infections; heart inflammation; ONJ; and possible atypical femoral fracture.

Emis Moderator comment: If it helps there is an article on our site linked below re Number needed to treat.

https://patient.info/health/absolute-risk-and-relative-risk#nav-1

I don't think that checking bone density more often than annually is considered to yield results that are statistically meaningful. Plus I believe that DEXA scans deliver some radiation, albeit small doses, but radiation-exposure effects are cumulative.

 

I took a couple of Tai Chi classes last winter, also for the purpose of trying to improve balance. However, I had to discontinue, due to a broken wrist after falling on black (invisible) ice. I was disappointed in the class, though this was partly due to its being too big (about 30 people) for any individualized attention as to form. Each time I went, I found myself watching the clock, eagerly anticipating the hour's end! I think I'm just not cut out for Tai Chi or meditation. Anything that helps with balance -- if in fact Tai Chi actually does that -- is beneficial in that it could prevent some falls. That said, I don't think it does anything for improving bone density.

 

Similar to in the past on this site, I'm hesitant to be a wet blanket, but: a doctor saying that no other of her patients have had adverse effects from this or that drug would do absolutely nothing to reassure me. This is such a typical comment from doctors, akin to their all-time favorites that "X, Y, or Z is a VERY RARE side effect" and "I've never heard of X, Y, Z drug causing X, Y, Z side effect before."

 

This may apply to other doctors but not this one. She would state the truth. So far, none of her patients are reporting adverse side effects. I had to ask as she did not volunteer the information. They may not have been on them very long.

One patient was having some serious health issues which sounded terminal so she mentioned her but could,not include her in the assessment as too much else had gone wrong with her. Sounded like cancer!

I think I want to know for my own decision making. Also, I read somewhere that the machines yield different results so maybe I am hoping for a better result and see how my natural addressing of it has helped.

That explanation of number needed to treat is SO good.  I'm keeping that link!  Thank you Emis Moderator!

Hi Allison, I don't know about that. My brother is a GP, has been in practice for just over 35 years with a patient list of over 2,000. If he says to me that he has never seen one case of ONJ in a patient on Fosamax, as he did, (but did not think it was the best one for me), that has to count for something. And if he adds that, having spoken to colleagues in the city, that they haven't see a case either . . . . Well, I don't know, I know it's not a proper experimental finding, but again . .  And, anyway, WHY on earth would a doctor lie or try and mislead????   J

Juno, I don't think a doctor would deliberately lie or mislead; I'm not that paranoid. What I do believe is that many doctors are obtuse about cause-and-effect when it come to meds and their side-effects and/or they are so enamored of a particular drug or treatment that they have blinders on. I could give a number of firsthand examples in relation to other drugs I've taken (as you know, I've not taken any osteo meds) but they might seem irrelevant in this context.

As for doctors with long lists of patients who have taken Fosamax but have never encountered ONJ in them, it is hard to quibble with this either pro or con. However, with the dental profession now concerned about ONJ and with patients being instructed to get their dental work out of the way BEFORE commencing a bisphosphonate, that's a problem in itself, as how can people "plan" their dental needs for the next ten-plus years (I'm using "ten-plus" to reflect long half-life of bisphosphonates). Dentists, at least in the U.S., are the most rigid, conservative bunch of practitioners you can find; if they feel there may be even a RISK of ONJ, they are not going to be eager to do dental procedures in someone who has been on a bisphosphonate. So one's oral health becomes captive to one's osteo-med regimen.

 

Yes, I'd say you're quite right about the dentists. But if a particular med. is known to have a risk (however small) of any significant kind, isn't it sensible to prepare ahead for it now that you know ??? It doesn't necessarily mean that there's a tsunami of ONJ waiting in the wings. (I know you didn't say that!).  Anyway, ONJ only arises as a risk after an extraction and most dentists try to hold on to a tooth at all costs . .. and root canal work is an alternative (according to my dentist) . . . 

 By the way I do remember you talking of your experiences with the PPIs. - you are most entitled to be questioning and skeptical of doctors since that.

 J

 

You have an excellent memory re: my PPI problems. Yes, that was a prime example of a so-called relatively safe medication causing all kinds of problems, including, I suspect, my osteoporosis.

You cannot prepare ahead, as you say, for dental issues. I've had a number of dental problems, and they almost always have arisen suddenly, with a recommendation to treat ASAP, not in ten years when the effects of a medication with a half-life of ten years have subsided.

I've come across a number of articles by dental practitioners who do not just cite only extraction as a risky procedure in the setting of an ONJ. In fact, they include local anesthetic such as novacaine injections in the list of risks! Anything considered even mildly invasive is considered risky. I've had several root canals; you would not want such a procedure without plenty of novacaine, I can assure you.

Also, ONJ can arise in the settintg of NO procedure whatsoever, as simply jaw pain or failure of an oral lesion to heal. The mechanism of bisphosphonates, as I understand it, is that they actively prevent formation of osteoclasts, which are what is needed for bone healing.

Finally: articles citing ONJ risk have made the points that ONJ is considered essentially untreatable and also that there are no data showing the risk of ONJ subsides just because a person ceases to take the bisphosphonate. (Again, because of the staggeringly long half-life.)

A

 

Above, I meant "in the setting of bisphosphonate use," not "of an ONJ."

 

To be fair here, I wouldn't be keen on being told to wait 10 years for the next appointment either!!  Many dental problems indeed can be urgent ones - but extractions are always avoided if possible. Re. ONJ with dental injections - I don't know how this would happen since the injection is into soft tissue and wouldn't involve the bone ???  

As you say ONJ can occur without dental issues being around - in fact it's also the case that ONJ can develop in persons who've never taken bisphosphonates . . . .  

Finally, ONJ is untreatable except for antibiotics. Then either it can improve by itself. or not.

BUT, before we scare the wits out of anyone taking bisphosphonates who is reading this, we have to alude to the fact that this condition is very rare ((one in 10,000 people). Even if you think this figure is too low (ie. cases underpreported) and the figure is, eg.,  three times this figure, it's STILL really low - and most people do not have major issues . . . .  J

My oral surgeon has treated many cases of ONJ and also told me how to check for risk when having extractions and even to return to him if I needed that when on fosamax.

I think that even one person reporting significant side effects is one person too many in my books.

My GP took my concerns very seriously and takes on board everything I have to say and will watch with interest my endeavours to improve my bone health without fosamax.

Injection of a local anesthetic can apparently trigger ONJ, as can any type of oral infection. So definitely not just extractions that are risky. I've read that ONJ is more common in people who take bisphosphonates for cancer treatment, as in them the drug is administered via an IV route. And that it's also more common in those taking IV bisphosphonates, such as Reclast (the drug the doctor tried to talk me into taking, showing little-to-no interest in my history of dental problems), for osteoporosis, than in those taking oral Fosamax.

As the oral bisphosphonates become less popular due their highly unpleasant GI effects and lack of being able to adhere to the regimen being very common, more people will be steered toward IV bisphosphonates, as IV bypasses the esophagus. In fact, it's because I have a history of GERD that the doctor tried to get me to agree to Reclast injections.

I'm not trying to scare anyone or even to influence what is a personal medical decision. On the other hand, I believe the osteo drugs are highly dangerous and not worth the risk for many. I think the catastrophic effects are being severely underreported and that time will tell. My guess is that, in even five years' time, these drugs will plummet in popularity since we're on the road to an impasse, whereby the medical establishment now states that it's risky to take the drugs for more than a few years yet any gains that might be made are likely to be lost if the drugs are discontinued for long. So patients are being placed in the impossible situation of having to choose to take risks for what is likely to be only short-term benefit (if any).

Something seems askew when an oral surgeon reports "many" instances of ONJ whereas a GP, e.g., Juno's brother, has seen "none." The explanation that seems most likely is that people who have the problem are more likely to see a specialist vs. a GP about it.

My GP (usually called PCP, for primary care provider, in the U.S.), like yours, is supportive of my decision to avoid osteo meds. On the other hand, I've had to put up with a lot of scare tactics from the endocrinologists and rheumatologist. There seems to be a high incidence of physicians "bullying" patients about these meds, which is a red flag in itself.

 

Apparently biphosphonates and other osteoporosis drugs are not the only causes of ONJ.  The oral surgeon advised against Prolia. I think it was because of the six monthly one off injection but also some other reason but I cannot recall it now.

He could work around the fosamax. Under three years was not an issue and after that date a blood test would advise the safety of having extractions.

A GP is not a specialist and is only as good as their willingness to be open to seeking answers from other sources for many of the medical problems they have to deal with in their patients.

 

I saw this post after I had replied to the other one wherein I stated there were other causes for ONJ.

I think that with the number of people posting on different sites about their side effects people will become more cautious about taking the drugs.

I could not bring myself to start the fosamax although I actually had picked it up from the chemist.

I am just being paranoid about falling especially with vertigo. 

So, the question is, if someone is on biphospohonates and suddenly needs a local anaesthetic in their mouth, or an extraction etc. what can they do?  It sounds as though there are no options, because it has such a long half life, and dental treatment like this would be an emergency.  I THINK I did read somewhere some time back that antibiotics should be started before the treatment though?  BUT also read yesterday that they reckon five courses of antibiotics over a 5 or 10 year period (can't remember which) put you at 53% higher risk of developing diabetes!  So one thing leads to another!

Kathleen, what would the blood test be for, before having extractions?

Too right about a GP and my lot are little better than a factory conveyor belt where you go in, they pick a prescription, no discussion, and you're out.  For instance, a few months ago I mentioned that there had been research that showed paracetamol shouldn't be given long term at high doses for arthritis.  They'd never heard about that.  I still have it on prescription.  Just don't take more than 2 tablets a day, and that's at night.

Yes, I am away from home at the moment at our daughter's place but the blood test is something like CBX which checks levels that tell you whether it is safe to have an extraction or not. 

The oral surgeon wrote down the details for me and I have put it away safely for the future.

He also said he would do the extraction in a certain way.

A good GP is worth their weight in gold.

 

Check their levels via a blood test. Go to a very good oral surgeon not just a dentist.

I would be more concerned with some of the other side effects now like the damage to the esophageas.

It would be very dangerous to be taking antibiotics preventively with the frequency described, diabetes aside. Overuse of antibiotics is the number-one reason why C. difficile colitis, a dysenteric GI infection, has reached near-epidemic proportions, as C. diff is often treatment-reistant. It tends to recur and can damage the colon permanently in severe cases. I'm not just saying this off the cuff; I picked up the infection myself three years ago (I was lucky in that it was successfully treated) following a course of antibiotics and have kept abreast of trends and and developments related to C. diff ever since, including through an online forum for patients, much like this one. Any situation that may call for preventive antibiotics, especially on an ongoing or recurring basis, is to be avoided at all costs.

I do not think you are being paranoid; falling is clearly the biggest risk for fracture, whether one is taking an osteo med or not. I've had a few isolated instances of vertigo so I can appreciate how much of a life-changer it could be if it were to become chronic. Does your GP have any useful suggestions for how to prevent a fall, should a vertigo attack occur?

 

Ah found it - it's CTX and 'An aid in monitoring antiresorptive therapies (eg, bisphosphonates and hormone replacement therapy) in postmenopausal women treated for osteoporosis and individuals diagnosed with osteopenia'?  I'd not heard of that.  I don't suppose my GP has either (Oh me of little faith LOL!).

Here's hoping we all hang on to our teeth anyway, regardless of osteoporosis or treatments or no treatments:-))))

I can't disagree with that Allison!  My GP has often prescribed antibiotics when there has been no indication of infection and I've not taken them.  It's just that I thought I'd read somewhere that someone needed to be covered on antibiotics if they were on biphosphenates and needing dental surgery.

This has just reminded me - we were talking about Tai Chi and balance.  In case it helps anyone, the exercise my husband and I both found VERY helpful was lifting one leg (he does it out straight but because of my knees, I keep the knee bent) and pushing out the OPPOSITE fist so the arm is stretched out horizontal to the floor, at the same time.  Then repeat with the opposite leg, and do this about 5 times.  When we started this I could only do it for a fraction of a second but it's noticeable how you can hold the position for longer as balance improves.

Hi Chris, I can't agree or disagree about the recommendation for antibiotics under those circumstances. My view is that if bisphosphonates, which are so risky themselves, force one into a situation where antibiotics are in fact advisable -- and they may well be in those circumstances -- then that is yet another reason to avoid bisphosphonates in the first place.

 

Well yes, certainly.  But it's easy for me to say that being under the level where it's recommended to be treated.  If I had really serious levels I think I'd be in a turmoil, still, although personally my inclination would be not to take biphosphonates, I think.  I'm still interested in the article that was in The Mail.  I just read up on it again on 'Growth Hormone treats osteoporosis in post menopausal  women' but I suspect it's very early days for this to be available generally, and there's no mention of side effects.  I guess it's too early for that too.  

Neither had my GP. She thanked me for the information and passed it along to her fellow doctors.