Prolia adverse events over 10 years - ONJ, AFF

Posted by Michael Lavacot @michaellavacot, Apr 25, 2024

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 😊.

Interested in more discussions like this? Go to the Osteoporosis & Bone Health Support Group.

Michael Lavacot | @michaellavacot | Aug 13 12:03pm

Hi @gma415 - This topic comes up a lot at trainings I go to. Dr. Michael McClung compares Prolia to other drugs like cholesterol drugs, or blood pressure medication. Trials for those drugs typically run for two years or less, but people take them for the rest of their lives. Just because the trial data stopped at 10 years, does not mean you need to stop taking it. He also points out that the risk of adverse events throughout those ten years of trial data does not get worse so there is no indication that you need to stop. He just made this point again two weeks ago at the Santa Fe Bone Symposium and no one in the room full of doctors disagreed.

gma415 | @gma415 | Aug 13 3:50pm

THANK YOU! Now to see if the doctor and insurance agree. Hugely expensive to self pay but thinking it would be worth it!

vmcgrantham | @vmcgrantham | Aug 14 9:18am

In reply to @gently "You aren't out of the woods yet. Maybe you should wait to see if you suffer..." + (show)

@gently I am curious now I am on Forteo but because I have kidney problems, graves disease and auto immune and I am worried about jaw necrosis. they want me on Prolia or reclast. I heard prolia is better for kidneys and recast is not but I people stating Prolia is good. I need to make a decision soon

vmcgrantham | @vmcgrantham | Aug 14 9:22am

In reply to @michaellavacot "Hi @gma415 - This topic comes up a lot at trainings I go to. Dr. Michael..." + (show)

@michaellavacot I don't know where to turn my doctor constantly wants me on reclast knowing that have kidney stones a lot and graves disease (autoimmune) plus I am scared of jaw necrosis. evinity has risks of blood clot, heart attacks and strokes. I do not know where to turn right now I am on Forteo injections.But I don't think my doctor is looking into my health problems and it is hard to find one up in Northeast PA as it is .

Michael Lavacot | @michaellavacot | 5 days ago

In reply to @vmcgrantham "@michaellavacot I don't know where to turn my doctor constantly wants me on reclast knowing that..." + (show)

@vmcgrantham - Just because you have kidney stones does not necessarily mean Reclast or any other osteoporosis drug is contraindicated. Now if you have a low GFR, that's another story. I have kidney stones but they have yet to shake loose, which I hope they never do. As far as which drug you should choose after Forteo, it depends on your T-Scores at the end of your treatment. Get a DXA scan in the last month or two before the end of Forteo and then make the decision. Prolia might be in order, maybe Reclast or Fosamax, or maybe Evenity if you are still deep into osteoporosis. Once you know, then you can work through the risks for each versus the benefits of each. There are a lot of factors to consider.

I recommend you watch a training I put together on osteoporosis treatments and medications, especially part two https://www.youtube.com/@michaellavacot . But remember, I'm not a doctor and I only offer this information as additional information for you to work with your doctor. I do my best to gather the latest information but I'm sure I make mistakes.

dezzie | @dezzie | 1 day ago

Maybe going beyond just Prolea. Mum has had the lot. The bisphosphonates on and off for years, the teraparatide injections, and now Prolea for a number of years. A prior femur fracture repair gave way last year. I speculated as to whether her bones needed a little breather. She now has severe osteoporosis. So many fractures over the years.

Michael Lavacot | @michaellavacot | 1 day ago

In reply to @dezzie "Maybe going beyond just Prolea. Mum has had the lot. The bisphosphonates on and off for..." + (show)

@dezzie If you have had a fracture while on Prolia, that can happen. Prolia reduces the risk of fracture but does not eliminate the risk. If you wanted to try something, what I have heard doctors doing is adding a round of Forteo to the existing Prolia treatment. YOU DO NOT WANT TO STOP PROLIA to try Forteo. Stopping Prolia is really tricky. I have a training just on Prolia that should consider watching since your mom is on Prolia.

Please note that I am not a licensed medical professional, and the information presented in the video is for general educational purposes only. The content is shared based on my research and understanding as a patient living with osteoporosis. It is essential to consult a qualified healthcare provider for personal medical advice.