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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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Sorry to hear about your experience. It sounds like you did everything by the book and yet still had runaway CTX. That's what I'm afraid of since I have a high baseline CTX. I guess I will find out in about 10 years or so. I plan on trying alendronate right after Prolia then switch to Reclast when my CTX goes above my baseline. No trials to prove it out yet, but it might work.
WindyShores reminded me of this previous post. In considering medications, I feel it is important to consider the whole person and not just the bones. Some of us cannot afford to have our immune systems negatively affected.
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I found this about immune system being affected. I wish it were from a source such as Mayo or Cleveland Clinic.
https://www.drugs.com/medical-answers/prolia-weaken-immune-system-3553497/
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1 Reaction@michaellavacot isn't a high CTX okay with Forteo and Tymlos? The calcium being high is another story. These meds do raise calcium further for a few hours. Is your calcium high in blood or only in urine?
Sorry @whitesman , I have a bunch of questions but will settle on this one. Did you have any fractures during the 10 years of Prolia?
BTW, the CTX overshoot should only last about 18 months or so. Hopefully you can make it through without losing too much BMD. Alendronate is a good drug do don't be too put off about not taking Reclast. If you wait 2 hours after taking alendronate instead of 30 minutes before eating (use low calcium water if you can), you can get up to 40% better absorption. This is called out in the package insert if you want to look it up. Calcium stops alendronate in it's tracks.
You aren't out of the woods yet. Maybe you should wait to see if you suffer the prolia mistake.
No, no fractures during the 10 years of Prolia. May be it is just me because I have serious problems with my health. I hope you will be very good with Prolia and even in my case the biggest plus - no fractures, I am sure it is common with Prolia.
Thank you very very much for the info alendronate, hope I can do so (I have micro colitis too).
Interesting liquid's form the same absorption or not, I have thoughts about liquid , it is clear that alendronate is not for long time for me. Reclast in my mind because on the scale- fractures or 2 weeks horrible pain. I hope it is simply long way to work with insurance for may be half of dose.
I do not want to destroy your hopes but Prolia you think that it is possible to have with it results as you plan? I write this only for one reason , after Prolia must be Reclast or Evenity according the Mayo clinic book on osteoporosis. Michael, my list with diseases, the last is osteoporosis and I research it only now, what to do and I practically do not know anything about it.
Thank you , thank you.
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3 ReactionsI have heard of the urinary tract infection indication and hypocalcemia is definitely possible if you don't have adequate calcium intake (first hand knowledge here), there was also a small but significant cellulitis events in the main Freedom trial. I have not heard of the other adverse effects called out on the site you listed.
Attached is a slide that was also presented at WCO 2024 showing infection adverse events from the Freedom study. There were not any big standouts here. ~3880 participants in each group.
Hi @windyshores - High CTX is not ideal for any of the drugs I guess, except maybe the antiresorptives, but the fact that both Tymlos and Forteo will raise the CTX even higher is a concern I had. Nothing definitive from a trial I could point to though.
My blood calcium is fine ~9.5 mg/dL though I think my ionic calcium is running a bit high ~5.0mg/dL. I do have some thoughts on possible normocalcemic hyperparathyroidism but will know more after a few more doctor visits. Urine calcium is still way too high, even on thiazides. Uhg!