Prolia black box warning?

I do not understand the “black box” warning. I’m just learning about it on this forum. Dr. Never mentioned it. I have never tolerated medication well. This prolia is a roller coaster. One day I do frarly well the flat on my back with back pain. It sounds as if you have been through the ringer too. I assum you have many meds with having organ donations. My wish is Doc’s would listen to their patients and. Maybe even look at these forums. We all can’ be nuts! Best wishes

Hi Bob,

If you go back to the first post of this discussion, you will find that the moderator has helpfully added a note explaining the Black Box warning.

As it specifically relates to those with kidney issues and i recall you mentioned something about your kidneys in your earlier post, this should be something you want to discuss with your doctor urgently

All the best

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.

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.

Hi Michael
Good meeting you.
I will check out your youtube post and the one you mentioned in your earlier post with the doctors speaking on Prolia. Haven't done it yet.

I see our main difference being that I think there is a world of difference between losing bone back to where you started but not fracturing vs losing bone back to where you started while possibly fracturing 1-12 times. Anabolic meds without a follow up med are the lose bone without fracturing and Prolia is the lose bone and possibly fracture like crazy.

My bias here is that learning about that little idiosyncrasy of Prolia freaked me out and I rejected my docs recommendation to take it. I chose Evenity not my doctor. So I like to think Evenity is vastly superior, then I don't have to question my decision.

I realize that there are many more factors to consider in deciding on an Osteoporosis treatment but that one characteristic of Prolia was a decisive factor for me personally - so much so that I try to let others know of that risk as many don't. You are aware so I won't say any more.
I wish us both great success with our chosen med and beyond.

I've been on Evenity for 10 months, two more injections to go. Doctor highly recommended because I had a hip fracture 3 years ago. Also have Osteoporosis. Had my 3rd Dexa scan and I'm worse 33% under Frank Osteoporosis. I was very upset when the doctor repeatly told me not to fall. Tuck and roll if I do so. Brought Doctor all of my paperwork from previous Dexa's and sadly I'm not getting better. My blood work came back good. Feeling very discouraged, was hoping this medicine would really help me with my bones. I'm 62 years old, walk daily etc.

sbcher, you may have already experienced the largest anabolic effect of Evenity. Now Evenity will get busy orchestrating the cells that preserve older bone. I would suggest (without being asked) that you change medications, now. I like Forteo or Tymlos after Evenity because it restarts the bone anabolic (building) process.
It sounds as though Evenity is simply not effective for you.
Tucking and rolling is best if you are falling on purpose and have some time to organize your limbs. Parachuting for example. If you fall, you are going to try and catch youself. And you may.
Don't get discouraged. You haven't yet been advantaged by the most powerful drugs for osteoporosis.
Your situation is one of the reasons we should all be calling for bone markers.

Oooops, I have given my account of my 13 March appointment, but put it in the DEXA discussion.
Can I move my post ?
Thank you!

This is so true. I was faced with making a decision fast after an ankle fracture i sustained shutting off a lamp! Seriously. Had already tried the oral remedies, and seen improvement on the dexa scan.
The choices were Reclast or reclast... I worried over the side effects for a month, read everything i could, and finally chose Prolia...which ALSO freaked me out...and ive been an RN for 40 years.
i have had absolutely no trouble with the prolia. after my next scan i will switch immedately to reclast....and move on.
the point of my post is to say you can really drive yourself crazy with overthinking. I know i did. I am ready for reclast now...
# 1 get an endocrinologist... you can expect a wait for the appt. In NH there are about 4 in the state... get on the cancellation list... In the interim, move smarter, go to PT, work on your balance, strengthen your core, think about how safely you are moving.
Hang in there, but move forward...

Hi @thisoldewe and @artscaping.
Here is the link to your posts of your March 13 update https://connect.mayoclinic.org/comment/1032795/

Posts cannot be moved out of one discussion to another discussion. Please send me a message using this form if I can help further https://connect.mayoclinic.org/help-center/