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Prolia adverse events over 10 years - ONJ, AFF
I wanted to share a slide from last week’s 2024 World Congress of Osteoporosis where Dr. Serge Ferrari discussed a 10 year look at select adverse events of Prolia versus 3 years of placebo from the Freedom and Freedom Extension studies. The units are in rates per 100 subject years so keep that in mind. I compare the first 3 years of placebo to the 10 years of Prolia (denosumab) to make it easier to read.
Dr. Ferrari mentioned there was a total of 13 cases of ONJ (osteonecrosis of the jaw), all of which healed, and 3 total cases of AFF (atypical femoral fracture) during the 10 years. They calculated that Prolia was reducing 280 fractures for every one AFF.
One takeaway was that even with the reduced bone turnover on Prolia, there was not an increase in the AFF rate over time. This addresses the “brittle bones” comment that you might hear about. Perhaps the bones are “older” but the increased BMD seems to compensate. Bisphosphonates do not continue to increase hip BMD past about 3 to 5 years like Prolia does.
This is just a look at the numbers and in no way am I saying you will not have an adverse event on Prolia. A lot of people on this forum have shared their adverse events on Prolia. I just want to share the data from the studies.
This presentation segment was sponsored by Amgen (maker of Prolia), so keep that in mind too 😊.
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Prolia is apparently a great medication- until you stop it!
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7 ReactionsI must be missing something obvious. Year 1 of Prolia had an overall rate of 165 adverse effects per 100 subject years but the individual effects totaled only 52.6. Where are the missing 115 reactions?
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2 ReactionsI think they only listed a select few adverse effects. Not sure why they chose the ones listed over others.
Yeah, stopping is a bit tricky. If your non-treatment baseline CTX is high, you can expect a greater rebound effect than if it's low. And if you have been on Prolia longer than about 2.5 years, you have to plan on losing about 0.5 T-score after transitioning to a bisphosphonate. I plan on staying on Prolia until I reach about -1.0 to account for the rebound.
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1 ReactionMy doctors don't use Prolia unless there are absolutely no other options. My endo joked that he might prescribe it near retirement so he doesn't have to deal with anyone trying to get off!
@Michael Lavacot, -1.0 or even -2.0 is out of reach for many of us. No matter what I do, I will never get better scores than -2.5 in spine and femur neck will remain -3.5 or so. So many of us cannot afford to "plan on losing about 0.5 T score after transitioning to a bisphosphonate."
It is not just about bone density changes: it is about increased fracture risk as well.
I am not sure if there is more risk for females past menopause who no longer have much estrogen vs a male. Have you researched that?
The relative safety of 2-3 injections of Prolia in terms of rebound in showing up more on this forum and apparently McCormick encourages this. That is encouraging, because Dr. Ben Leder's video on YouTube shows how very effective Prolia can be, on its own or in a complicated combination with anabolic that he demonstrates. Again, until you stop.
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3 ReactionsI wish there was a footnote explaining their choice of adverse effects, or at least acknowledging the omission of so many. That would enhance the credibility of the report.
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1 ReactionHi @windyshores - I agree that Prolia is a last resort drug. I would not be on it now if I really had a choice. If your BMD is really low, there are almost no other ways to bring it down without using Prolia in your treatment plan somewhere. The only other option I know would be to use an osteoanabolic followed by a bisphosphonate, then back on an osteoanabolic. You could cycle this pattern until you achieved your target, but good luck getting your insurance company to cover it. The realistic path is osteoanabolic followed by Prolia until you can transition to a bisphosphonate.
I’m at -3.9 in my L2 spine after taking Evenity. I have no realistic path to get to a safe zone without Prolia. It might take 10 years or I might never be able to reach it. If Prolia stops working, hopefully new options will become available. I still have one trick left which is combination Prolia + Tymlos or Forteo. I’m going to wait a year or two before I make any discissions on that.
Fracture risk follows BMD pretty well. I understand the bone structure plays a big part in strength which is why I started with Evenity.
Not sure what you’re asking on the female versus male question. I’m on meds to raise my testosterone, which converts to estrogen and helps bones. If I were a female, I would definitely be on estrogen. My wife is on estrogen.
There is definitely a transition point when taking Prolia. I discussed this in the Prolia presentation I put together based on the trainings I have attended https://youtu.be/XiRN3UvOEYg?si=PpnSpazr00QF-rnz . The rebound effect is related to how long you have been on Prolia and your baseline CTX. If you have good enough bone strength after a year or two on Prolia, great, transition to a bisphosphonate. If not, you should likely continue on Prolia and factor in the rebound before you transition. This is the story I hear repeatedly on trainings.
@michaellavacot did you consider Forteo or Tymlos?
My plan is all set. I have done 2 years Tymlos, 4 months Evenity and now on to low dose Reclast. My femur neck is still not good though. Spine and hip are much improved.
If needed I will return to Tymlos then Reclast again.
I had breast cancer and am older. Estrogen is not an option. Maybe a SERM at some point.
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2 ReactionsHi @windyshores , I did consider Tymlos and Forteo after my dismal Evenity results, but with my high CTX and hypercalciuria, I did not think it was a good idea. I'm not even sure Prolia will work for me if I can't plug my calcium renal leak. Working on it!
Your plan sounds solid. I hope it works out for you 🙂
10 years on Prolia, stopped Prolia, Reclast, 2 weeks in the bed, thought wouldn't go through, after4, 6, 8 months of infusion high CTX, insurance refused give me Reclast even for my money, and no low dose at all, endocrinologist prescribed alendronate, that's all and I had fracture of my hand 5 months ago.
From my experience Prolia did not help me much, will come to the begining of treatment. My advice for new patients, look more and more what to do.
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