About to start Prolia: What's your experience?

I’m in the same predicament as you. I’m hearing so much negativity about this shot and quite confused. My doctor assured me that in all the time he has been practicing, he only had one patient with a side effect taking prolia. Does anyone know the difference between prolia and reclast?

I try to stay put of these discussions as I've posted about Prolia already on other threads. But in case anyone who's not taking it yet, and is considering doing so, I fervently hope the person does a lot of due diligence.

The FDA's FAERS website of post-marketing* reported adverse effects currently lists over 140,000 (sic) adverse effects for denosumab. I didn't even include a search for the brand name, Prolia.

Considering that it's not been on the market in the U.S. for a full decade, that is a terrible record. Add that the FDA also added it to "recommend for investigation" for vasculitis in October, 2021.

Add that the adverse effects include 33,705 reported reactions under the 'musculoskeletal and connectivity tissue disorders.'

The Wall Street Journal reported that the pharmaceutical industry estimates that fewer than 15% of adverse effects are even reported to the public-access FAERS website and one can reasonably calculate that the real number of adverse effects is easily over a million.

In the interests of full disclosure, a 'reported' adverse effect is not conclusive unless verified by thorough investigation. But when there are thousands of similar reports, suspect a trend.

I'm not taking the drug and, by that fact, some think that I shouldn't post anything about it. But I do have osteopenia and as far as I'm concerned, we all have skin in the game and can share facts about a drug that can be prescribed to any of us. My concern is sharing information so we can make thoughtful decisions about our own care.

If the logic behind taking Prolia is that it's injected or infused a few times a year and therefore convenient, there are other alternatives with a longer history of safety and efficacy. If the idea is to avoid bisphosponate risks, the same risks apply to Prolia as it also is a bisphosphonate analog.

In my opinion, separate from the pure facts above, it's a terrible drug and, as the number of class action lawsuits against Amgen because of accumulated and new side effects previously not reported. I wouldn't be surprised to see it taken off the market in the U.S.

*Post-marketing means after a drug has been approved by the FDA. What makes this important is that the FDA's scrutiny of a new drug is primarily involved in the pre- and approval phase and falls off to barely monitoring the drug post-approval. We frequently don't hear of the post-approval incidents until lawsuits start popping up. Caveat emptor.

Note: I tried to post the website link to the FAERS data on denosumab but it's an app and not showing a URL. If anyone wants to see it, go to the FAERS website, accept the terms, wait for link to Public Dashboard and follow the instructions. It's not very user-friendly. I've learned to document sources in anticipation of someone asking where I found data.

I started Prolia in October of 2022. No side effects after 3 injections. However, in April I had a molar that cracked , I did find an outstanding oral surgeon that was willing to pull the tooth. Then out of precaution I was put on high doses of Amoxicillin and NSAID. Developed NSAID toxicity and CDEf. Then put on Flagyl. One mouth of pure misery. Moral of this story, there is no guarantee that while on Prolia events ,not in your control, will arise. I would like to get off Prolia, however, my mother at 97 years old died after her spine gave out due to osteoporosis. For years she would not go on a drug,however, watching an amazing woman that was still playing classical music at 96 with no other health issue but osteoporosis was sad and hard to comprehend why she never sought some type of treatment. She lived the last 8 years of her life with her head bent to her belly button. She had multiple surgeries for painful fractures. We must all be proactive with our lives. Ask your doctor to compare your dexa scan from year to year. Ask for a CT bone scan. The more information we have the more we can make the best personal decision. My best to all.

Reclast is an IV infusion given yearly and Prolia is an injection given every 6 months. Both are primarily anti- resorptives.
Prolia, like Evenity is a monoclonal antibody that shows good results and would be my preference at this point. Both are made by the same company, Amgen.
I am halfway through the 12 month course of Evenity and as it is given only for a year, must be followed up with one of those 2 drugs. I can’t take anything oral so those are my options.
I had compression fx’s at thoracic vertebraes last December- (skiing) which healed on their own but revealed I have osteoporosis.
So that’s my backstory- I will see my endocrinologist in August to discuss the follow up.
My understanding is if I don’t continue with a drug to maintain the gains, I lose the new bone and even wind up worse off than before.
I struggled with the decision but at 63 and active, didn’t like the idea of more fractures.
I don’t like taking prescription drugs, especially a new one.
But I read the studies ( I’m an RN) and it seemed a reasonable risk.
I’ll report back after my appointment.

@windyshores and others
If someone builds bone with, say, Tymlos or another drug, then needs to segue to a bisphosphonate to 'protect' that gain, how long does the person have to stay on the 'protector' drug?

I think it depends. My doc said he would monitor and try to give me breaks. But I assume even with that optimal scenario it will be on and off. Also depending on monitoring doc would put me on another year of Tymlos (he might save it, we'll see after DEXA) or Evenity.

Good news for me is that I am no longer on cancer meds though I will say most of the drop from letrozole was in the first year.

I agree with all you laid out. I have had 6 Evenity injections and doing fine. Initially, had some pain and swelling problems with 1 arm but now manage that. After 1 year I will switch to Prolia for rest of ny life. I am 79, play tennis and walk several times a week. Very active life. My bone density was awful so I am following my dr’s advice. Happy with my decisions. Will have to learn to live with side effects. Do not want a bunch of stress fractures and broken bones at my age!

I had a molar extracted in month six of Prolia injection in Jan 2022 and waited until month 7 to get next injection. No antibiotic prescribed. No infecttion. The tooth healed.

I wish to goodness I had done the research you have done before I agreed to Prolia. I hope others will read your post carefully and take heed and not be where I am today!

Here comes the tricky part of the question. IF one goes on any bisphosphonate, including Prolia, after taking Tymlos, Forteo or Evenity, how does one avoid the known risks of the biphosphonates that make them so disliked? I mean, is it possible to build new bone with a drug, take a bisphosphonate to 'protect against losing it' and then get hit with the well-known downsides of the anti-resorptive bisphosphonates? I haven't found any info or studies addressing the seeming dilemma.