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Prolia black box warning?

Osteoporosis & Bone Health | Last Active: Apr 28 8:56am | Replies (59)

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@awfultruth

I get that Prolia is a complicated topic as it does have strong benefits but it has a risk that I'm not aware of any other Osteoporosis med having. That is a rebound effect that means if you stop Prolia you may not only lose the bone density you gained but you may experience multiple fractures in a short period of time. I've seen people posting about having up to 10-12 fractures by stopping Prolia and not knowing the possible consequences.

That is not what happens with Evenity, Tymlos, or Forteo. So far as reported people just lose the bone they gained if they don't follow the anabolic with an anti-resorptive. They do not report multiple fractures.
I don't use the word rebound for the anabolic meds. I like this definition for medical rebound effect "Stopping a medication can cause withdrawal (discontinuation) symptoms, the return of the original illness, and rebound. The latter means that the disease will return stronger, faster, or with greater likelihood than if it had not been treated with medication".

So the "rebound" portion of the definition is where the condition gets worse. 1-12 fractures from stopping Prolia without immediately starting another med is definitely worse. Losing what you had gained with an anabolic is not what I consider a rebound.

Keith McCormack offers a possibly safe effective brief use of Prolia immediately followed by Reclast. I'm still thinking about that one.

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Replies to "I get that Prolia is a complicated topic as it does have strong benefits but it..."

Hi awfultruth,

I love the member names on this site.

Okay, fair enough. I guess is comes down to the definition of rebound effect. You will lose a significant amount of BMD by stopping Prolia, Evenity, Tymlos or Forteo without follow-on treatment. To your point, I can’t find a study showing fracture rates after stopping the osteoanabolics, but you can find studies showing the sudden loss of BMD (attached for Evenity) https://doi.org/10.1002/jbmr.3452. I do seem to recall there is an increase in fracture rate after stopping the osteoanabolics without treatment but I can’t remember where I saw it.

Now just to be clear, the multiple fractures after stopping Prolia is when patients do not immediately follow treatment with a bisphosphonate like Fosamax or ReClast. You can see the data of fractures after Prolia both with and without follow-on bisphosphonate treatment here https://asbmr.onlinelibrary.wiley.com/doi/full/10.1002/jbmr.4335. Lot’s of good data in this study on Prolia and breaks.

I put together a Prolia training of sorts and cover the data I have on stopping Prolia and what to expect. If you want to get deep into the weeds, it's posted here https://youtu.be/XiRN3UvOEYg .

Finally, I'm not a doctor. I'm doing research for myself and others to work with their doctors to help achieve the best results. I don't get paid for any of what I do here, I'm just a retired engineer trying to help others.