Hi everyone! There has been a lot of discussion lately on this forum about the osteoporosis drug denosumab aka Prolia (americanbonehealth.org/medi.... Some of you have expressed concern about warnings that discontinuing twice-a-year injections without starting another medicine can cause "rebound" symptoms including low bone density and broken bones.
A new study from Israel takes a closer look at the data to see how prevalent fractures can be among patients who discontinue denosumab vs. those who persist with treatment. Researchers also identified who might be most at risk of these rebound symptoms: “We showed, for the first time, that among discontinuers, risk factors for those fractures were renal and cerebrovascular disease.”
Read more about it here (bit.ly/33GEDbP), and let us know what you think!
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Mark_ABH
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Thanks for posting this interesting research Mark. I suffered 8 spontaneous vertebral fractures last year having been put on a drug holiday following completion of a 3 year denosumab course. However, I had no other medical conditions apart from osteoporosis - no renal or cerebrovascular disease to my knowledge.
Only after the fractures and two kyphoplasty/vertebroplasty surgeries to repair the worst fractures. I had a Zoledronate infusion a year ago - as a firefighting exercise as something had to be done. Then, as I now am classified with severe osteoporosis I qualified for Teriparatide (Forsteo) which I have injected daily since May. The problem was that immediately following the 3 year Prolia course, a DEXA scan appeared to show excellent results - 1.9 spine (osteopoenic) and -0.9 hip (lower end of normal) so the hospital advised a drug holiday. What they did not know was that these results were artificial, that bone density would rapidly plummet and that without a relay drug, I'd suffer fractures. A year after that deceptive DEXA scan, a follow-up scan showed -3.7 in my spine. All this has been life changing for me - and not in a good way.
That's too bad your physician didn't know to put you on something else (bisphosphonates for example) after you discontinued Prolia. Some advocates want even more prominent warnings about this "rebound effect" on the product label. Best wishes for better health.
Thank you. I'm working at improving core strength & balance with Pilates, walk when I can & take appropriate dietary supplements. Also keep up to date with developments by following this useful forum.
Hi. Interesting that you were RX Foreto (Forsteo) AFTER instead of before your multiple breaks. It is the drug of first use after the first breaks appear to prevent breaks, not mend them. Periodically I read on the Bone venue that women in England are provided Forseto as a last ditch hope after other meds had been used, or she cannot tolerate the other available OP meds available on the health plan there. This medication works entirely different than other OP meds. Sorry you had so much happen to you. I finished my 2 years on Forteo resulting in a 12% increase in bone density WHERE I needed it. Immediately after the two year Forteo was immediately had a genericReclast infusion so there was no time to lose the improvement from Forteo. Next infusion is due in 6 months, but the rheumatologist will discuss what the next step will be prior.
My best wishes for continued success with your Forteo. It is so expensive but worth it, and there are some ways to apply for financial assistance if a private insurance doesn't cover it.
Thank you very much for your good wishes & encouragement. Here in the UK, it's possible to qualify for free treatment with Forsteo (teriparatide) for up to 2 years on our National Health Service if certain criteria are met. One of them is a T score of at least -3.5 somewhere in the body. My consultant still had to refer my case to a special panel for approval and that's why it took several months after the fractures, before I received the drug. As stated previously, the spinal reading was -3.7 and that, together with the multiple fractures, enabled me to receive Forsteo free. The consultant has said that when I finish the 2 years of teriparatide, I'll need another Zoledronate infusion and that I'll remain on some kind of drug for the rest of my life, with the occasional drug holiday, which I hope they'll monitor more carefully after what happened after the denosumab/prolia. But I'm really unhappy about all this. I'm interested to know how your treatment continues in the future.
Hope only the best care for you. I know if a med is covered by the health plan in England, there should be no cost to you. I am just so sorry Forteo (Forsteo) wasn't used first, after your first fracture. You are correct as in one's lifetime, at the present, Forteo is limited to two years. Has to due with the time of the testing and trials were done before the FDA approved its use in 1990. The results were very good and the FDA approval in just two years testing is remarkable. Here it is the med of first choice early as possible for OP, not as maintenance med.
Think perhaps why you were not offered Forsteo early was it's cost. Retail cost in my USA area code is over $3000 per 28 day pen injector.
No panel or other administrative authority or significant OP breaks required here. The goal is to catch OP breaks early and the doctor decides whether to RX Forteo.
And you are correct, we will need maintenance of some sort to control the OP. My doctor placed 3 options on the table after my 2 years of Forteo was coming to an end. I asked which one he would RX for his mom or sister. Boom! Instantly he picked up the genericReclast annual infusion. (I had asked him the same question when he placed Forteo, Prolia and another option when he sad I needed one. BOOM! Forteo.
Guess that is a good question to ask. My best to you in your maintenance of your OP.
You have to fight to get Forsteo early, at no cost; we have the choice and must find a way to pay for it. Either way, neither f our health systems are perfect, but we have an option to find ways to pay for the meds.
So sorry you went through this. Only positive outcome was that the surgeons created a permanent brace around your fracturing vertebres so they won't collapse.
This is the way HealthUnlocked works now. It checks whenever you click a link, and then you have to click again in order to get to the site. It's just a little security speedbump I think. This information may help Badsideeffects as well.
It is totally correct what HeronNS says. Goodness knows why one has to click twice but that is what one has to do! It worked fine for me just now when clicking on the link from the Administrator. You have to click twice to open the link.
Interesting, especially in light of the fact that Amgen supported this study. "Disclosures: Amgen supported this study. Tripto-Shkolnik and one other author report receiving personal fees from Amgen and Eli Lilly."
Yes, I thought that too. And then I wondered if Amgen would use it to encourage patients to remain on Prolia/Denosumab as their fracture risk is apparently smaller if they stay on it. Or have I misunderstood the article? Probably as I'm not too good with scientific data....
I think the idea is to show the risks are limited and you are more safe taking the drug than not. Big Ph.... is very sneaky. There is currently showing on Canadian tv a commercial for Prolia which doesn't mention osteoporosis but shows a little girl growing up and becoming a successful person and growing old and maintaining her energy etc., all in the interests of implying that Prolia will keep you young. They are not allowed to have full-fledged ads for prescription meds, but several types of drugs circumvent the rule by never being explicit about what the drug can really do. This Prolia ad is the most egregious I've seen. Unlike the US there is no spoken list of warnings and possible side effects although possibly something on the screen in microscopic print, I didn't notice. Completely misleading. I've complained but yet to hear back whether the authorities will look into my complaint.
Thanks Hearon for this information. That’s so disgusting and so typical Amgen. Big Pharma. Make the money and not care about the people Reminds me of FDA getting everybody hooked on cigarettes when they knew they were over 2000 addictive properties besides the nicotine. Then once they had to stop the ads, the cigarette companies go to Iran and overseas and hook the women there. It’s always about money
Hello Mark in the USA. Do something about Amgen! Prolia is the devil Drug. It has destroyed my life The black box label was not on Amgen’s product before I took the shots. I am very angry at this company and the FDA. They’ve had plenty of complaints and they still let Amgen keep this product on the market. I think it is disgusting that the FDA allows us to continue. When I told my endocrinologist that it felt like my body was eating itself when this symptoms first started happening he told me I needed to go on head medication That was two years ago I am officially bedridden and in constant pain. I’m sorry but I cannot read any propaganda because I think the FDA is full of crap and so are the doctors in the USA, especially in Florida.I don’t have time to list the other side effects but Prolia has destroyed my life
I am SO sorry to hear about your terrible experience with Prolia. The sad stories told by you and others have convinced me not to take it. I'm sure my doctor will be very angry (and that makes me sad), however, it's MY body, not his!
Hi - I came across the Israeli article about a week ago while researching the incidence of rebound fractures after discontinuing Prolia. It makes for interesting reading as it's one of the few published papers I've found which gives statistics on fracture rates. Seeing that the research was supported by Amgen does make me somewhat suspicious that the results are possibly not as comprehensive as they would be if done independently, though.
This is really important to me right now as I'm in the unenviable position of having to discontinue Prolia due to a series of adverse reactions I've had to it over the past two years (four injections). Unfortunately I then found that the bisphosphonate I was prescribed (weekly Actonel 35mg) to try to transition safely off Prolia produces nasty side effects as well, so was not tolerable. I was only able to take two of the weekly tablets before having to give up. I then tried Actonel 5mg (daily tablet) every second day (my suggestion) to try to drip feed it into my system instead of hitting it once a week or month with a high dosage. This was reasonably manageable although I felt dizzy, nauseous, had slightly blurred vision and just felt drugged. I couldn't imagine spending the next year like that, so I stopped taking it after 2 weeks. My GP wasn't sure if taking it every second day instead of every day would be effective anyway - there's so much about these drugs that they just don't know. I'm caught between a rock and a hard place at this point, and need to figure out what to do quite quickly as I am now 7.5 months past my last Prolia injection, and am getting extremely worried about rebound fractures.
I'm trying to work out the odds of NOT having rebound fractures, so am trawling through the medical literature to try to get an idea of how prevalent they actually are. Presumably it's not a given that everyone who discontinues Prolia will fracture one or more vertebrae? Someone I know through a mutual friend told me that she was on Prolia for a couple of years before stopping it for about 18 months. This was in 2016 before the potential for rebound fractures was common knowledge. She didn't have any fractures but is now back on Prolia, so it's impossible to tell what would have happened after a few more years of discontinuation. The Israeli study appears to indicate that the incidence of vertebral fractures is about 8%, but of course that's from a trial of a relatively small group of people, so one can't really extrapolate with any confidence, especially with the hand of Amgen at the tiller. There has been so little written about this in the literature. I phoned Amgen Australia today to try to get their input on fracture incidence, but the person to whom I spoke, despite sounding very concerned and helpful, made it clear that he was not a medical professional, and so was unable to provide any input about rebound fractures beyond that which he read to me from the current package insert.
Reading the posts by 8fractures really scares me. I am a fit, healthy 65-year old female who exercises a lot by walking up to 35km per week, eats a Mediterranean diet, has a healthy lifestyle, etc. I was diagnosed with OP in 2012 when I decided I would have a DEXA scan to set a baseline. You could have knocked me over with a feather when the results came back (T-scores -2.2 spine, -3.1 femoral neck, -3.1 total hip) as I'd always had a very healthy diet with lots of yogurt, green vegetables, whole grains, no red meat but chicken and fish instead, lots of mineral supplements, exercise, etc. I resisted taking the Fosamax which was recommended to me as I'd read all the bad press about bisphosphonates, instead managing to improve my BMD using supplements for the next four years (-1.9 spine, -3.1 femoral neck, -2.8 total hip in 2016). Then in January 2017 my BMD dropped on a DEXA scan, due to bad lifestyle choices at the time, I think. Regardless, I still thought I was invincible until Aug 2017 when I got my foot caught while jumping off the back of a motorbike very quickly and awkwardly, tugged and twisted - and crack! I had fractured my left tibial plateau. What a wake-up call that was...
So, after 4 months on crutches and faced with a declining BMD, I let myself be scared into taking Prolia - the biggest mistake of my life and one I will always regret. I basically lost almost two years of my life to the side effects. It was only after the fourth injection in September 2019 when I got a bright red swollen itchy rash on my face and eyelids and had to go to Emergency with acute chest pains as well as struggling with a bladder infection which came out of nowhere that I put 2 and 2 together and realised why I had been feeling so ill for the past two years, as all the strange medical events had occurred very soon after a Prolia injection. The new GP I started seeing took one look at the rash and said I was allergic to Prolia and told me to stop taking it (my previous GP maintained that none of her other patients had any side effects on Prolia and refused to consider it as the reason for my multitude of medical problems!). Easier said than done to stop taking it, I then found out, to my horror. I was not told in 2018 before my first Prolia injection, either by the prescribing endocrinologist nor the GP who oversaw its administration, that it had the potential for causing rebound fractures if discontinued.
So here I am, really scared as to what could happen as I feel the clock is ticking, and trying to work out a way forward. My research indicates that the most effective option is a 5mg infusion of Reclasta which apparently maintains most of the BMD gains made while on Prolia as well as protecting against rebound fractures. However, with my short experience of Actonel's unpleasant side effects, I've realised that I'm probably a candidate for nasty side effects from the Reclasta infusion as well - and then it's in my system for a year! Complicating matters is the fact that I live on my own which also makes it really difficult if I'm ill (as I experienced with Prolia) and can't look after myself. My new GP wants me to consider HRT (the transdermal patch) which I've been researching for the past week. I can't see any evidence that it protects against rebound fractures, but I'd really appreciate some input on this. The default option is to cross my fingers and hope that I'm one of the ~90% of people who DON't get rebound fractures, but is that figure accurate and is that too much of a risk?
Hi, thank you for sharing. None of us is qualified to comment on your individual case, which is unfortunately quite complicated. I'd suggest you check out the resources available from Osteoporosis Australia; here is their rundown of treatment options: osteoporosis.org.au/treatme...
Have you explained to your physician your concerns? It might help if you lay it out like this:
- Prolia causes unacceptable side effects, but discontinuing it raises the risk of rebound fractures.
- Bisphosphonates also cause unacceptable side effects.
- What could I take to slow or reverse my bone loss and avoid rebound fractures due to having discontinued Prolia?
You might need to ask for a referral to an osteoporosis specialist (particularly an endocrinologist) if your case is too complex for a general practitioner.
I do realise that I can't get qualified advice from this forum, but am hoping to get opinions, suggestions and hear of other people's experiences which might give me some idea as to how to proceed. Perhaps I should have started a new thread? I'm new to this, so please point me in the right direction if I have posted incorrectly.
My current GP is across everything to do with OP. I did contact Osteoporosis Australia a couple of months ago and they put me in touch with another GP who is quite prominent in the osteoporosis community in Western Australia. She gave me the same advice - take a bisphosphonate to prevent rebound fractures (which I can't without side effects). It seems the options are very limited, and this is what I have read in the medical literature as well. An infusion of Reclast appears to be the recommended treatment but I am terrified that I will have even worse side effects than with Prolia and then be stuck with them for 12 months.
I have seen an endocrinologist. She prescribed the weekly Actonel 35mg which came with intolerable side effects. She's away from her office until next week so is unaware of this, but I have sent a detailed email to advise her. In the meantime, my GP took charge and we tried me on the daily 5mg of Actonel but taken every second day. I've given up on that due to feeling unwell on it, although it was almost tolerable. So what to do now - hence my posting on this forum. The GP is suggesting hormone replacement therapy via a transdermal patch, as I mentioned, but I can't find any evidence that this will prevent rebound fractures. I was hoping someone in this community might be able to provide some input from their own experience.
I am hoping someone can provde information about endocrinologists in the USA who are experienced in the treatment options and nuanced issues related to prolia discontinuation. Or provide information on how I can research finding one. My endo doctor does not seem to be up to date on the studies as she recently told me the peak rebound was at 6 months in the face of my max rebound which appeared between 7 months and 21 months discontinuation This most recent summary study says peak is 18 months. It may still be going up. She has ordered no bone turnover marker tests since 7 months. I need to understand fully the future consequences if each of the options for rebound as all of them seem to have similar long term consequential issues which I do not understand. That is how all of us got into prolia problems in the first place. Evenity provides gains but is one year old.. no history and gains are lost if it is stopped. What else happens if it’s stopped. Also an Amgen Drug. Reclast is now being discussed as an issue with bone repair if you break a bone due to the substantial bone formation suppression long term. . It seems the solutions are all a series of add bone , remove bone patch jobs for rebound effect without comprehension of the long term consequences of any of it. It is clear to me that the osteoporosis treatments have messed with Mother Nature in ways poorly understood. New research shows that the turnover process is not sequential but is interlocked. So stopping turnover stops formation. So not only do you have the loss of bone mass on rebound ..new bone can’t be made until the body can balance the densities of the two activators. In the hast to correct the fracture risk of rebound I fear more long term problems are being created.
I have been on fosamax as a relay drug since 6 months after my last prolia injection which is 21 months of fosamax. Notwithstanding I have lost 12 % of total lumbar spine and 5 % of femoral neck and hip. All far greater losses than any gains from prolia. I have gone from a normal spine at baseline ( pre prolia) of -8 to osteopenia at 1.2 in 21 months. I really need a doctor who will analyze my risks not just hand me more bone drugs without helping me understand the relative risks of each option.....or simply admitting they have no clue. Do you have any resources to find experts in this issue in the USA. All the major clinical literature seems to be Europeans or Israelis.
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