IV Zoledronic acid.

[Lion321]

unfortunately time to move to Zoledronic acic fractures happening. Tried calcium and Vit D weight bearing exercises.

Has anybody got any advice before I travel down the road of no return!!!

thank you in advance.

[Maxone73]

I am far from fractures but they still got me on ZA for prevention and also because it seems to give a hard time to bone mets progression.

The only thing I have been asked to do is to fix my teeth if I needed to. Teeth extraction can be harmful while you are on ZA, very harmful, they have to fill you with antibiotics at best. Dental filling is not a problem, but whatever exposes the jaw bone can be a big deal.

[RyderLake1]

Hello,

My medical oncologist recommended Prolia (denosumab) for bone strength. In higher doses it is called Xgeva. I have been on Prolia for 10 years and 8 months. He said at the time Prolia was easier on the kidneys than Zoledronic acid. Good luck!

[Lion321 in reply to RyderLake1]

Thank you very much for your reply. I will check it out.

[Jewelrylady in reply to Lion321]

My husband is also getting Prolia injection every 6 months. So far, he has had no side effects from it, but he’s only had two injections so far. A friend of mine (who is a woman) has been taking it for four years with no problems. Reading the side effects that are possible is pretty scary, but everyone responds differently!

[Tall_Allen]

Discuss taking Celebrex with it. The combination decreased mortality by 22%:

ascopubs.org/doi/10.1200/JC...

[maley2711 in reply to Tall_Allen]

To clarify...... Zoledronic Acid does not have level 3 evidence to suggest as SOC? To replace or be combined with abiraterone?

[Tall_Allen in reply to maley2711]

Sorry, I have no idea what you are talking about. Zoledronic Acid + Celebrex has level 1 evidence that it decreases mortality.

[maley2711 in reply to Tall_Allen]

Thanks.....much more required for a SOC....just wondered, as you suggested showing to his MO.

[Tall_Allen in reply to maley2711]

Nothing is higher than Level 1.

[maley2711 in reply to Tall_Allen]

thanks for correcting my woeful memory!!!

[Radars in reply to Tall_Allen]

hi,I have L5 t12 severe and I have had 1 reclast infusion, am I stage 4 osteoporosis, I had a dexa scan in 2022,-2.5 4.1lumbar spine, bmd at femoral neck 0.593, vfa superior end-plate deformity at t12, my next infusion is this April I am in 2 minds about having it because of the horror stories, any help please.

[Tall_Allen in reply to Radars]

You clearly need it

[Radars in reply to Tall_Allen]

with my scores am I in the end stage of osteoporosis, I also have marked facet arthropathy in the lower lumbar spine, mild to moderate wedge compression fracture of t12 no other fracture demonstrated.

[Grandpa4 in reply to Tall_Allen]

I am confused. At several points the manuscript states that there is no mortality benefit. Is there some subgroup I am missing?

[dentaltwin in reply to Grandpa4]

I find it confusing too (maybe because I haven't had my coffee). The arms are SOC (ADT only), SOC+Cel, SOC + ZA + Cel, and SOC + ZA. I saw this:

"There was no evidence of a survival advantage for SOC + Cel (HR, 0.98; 95% CI, 0.80 to 1.20; P = .847: 143 deaths [117 deaths related to CaP; 82%]); median survival was 70 months; and 5-year survival was 54%. Nor was there evidence of a survival advantage for SOC + ZA + Cel (HR, 0.86; 95% CI, 0.70 to 1.05; P = .130: 138 deaths [103 deaths ..."

This is overall survival. Remember that selective COC-2 inhibitors are associated with cardiovascular events. The comparator apparently is SOC alone.

There is also this:

"Adjusted competing risk regression for CaP-specific survival showed no evidence of advantage over SOC-only for SOC + Cel (sub-HR, 0.97; 95% CI, 0.77 to 1.23; P = .782) but an advantage for SOC + ZA + Cel (sub-HR, 0.74; 95% CI, 0.59 to 0.94; P = .014). F"

So the benefit for prostate-cancer specific death appears to hold up, not so much for overall survival (the suspicion is that the cardiovascular events went up with Celebrex).

But in the discussion, the subgroup of M1 patients DID see a benefit in overall survival:

"However, a preplanned subgroup analysis suggested the possibility of benefit in terms of both survival and FFS for SOC + Cel + ZA over SOC alone in M1 patients at random assignment, although the test for interaction was not significant at a traditional 5% significance level."

So yeah, I'm still a little confused.

[Tall_Allen in reply to dentaltwin]

see above reply to Grandpa4.

[Tall_Allen in reply to Grandpa4]

These analyses are written for other researchers- these aren't written for patients. I'll translate:

"Preplanned subgroup analyses in men with metastatic disease showed a hazard ratio of 0.78 (95% CI, 0.62 to 0.98; P = .033) for SOC + ZA + Cel."

"Preplanned subgroup analysis of metastatic men" means they had planned to look separately at the men who were metastatic. (Their trial had non-metastatic men too.)

"Hazard ratio of 0.78" means mortality was reduced by 22% (1.00-0.78)

"95% CI, 0.62 to 0.98; P = .033" mean sone can have good confidence that it wasn't just a statistical fluke.

" SOC + ZA + Cel" = standard-of-care (ADT) + zoledonic acid (Zometa) + celecoxib (Celebrex)

[dentaltwin in reply to Tall_Allen]

That .78 HR is compared to "SOC"?

Thanks for wading through this--my eyes were starting to cross.

[Tall_Allen in reply to dentaltwin]

Yes -compared to SOC at the time, which was Lupron, Zoladex, or similar.

[dentaltwin in reply to Tall_Allen]

Thanks!

[Lion321 in reply to Tall_Allen]

Thank you for your reply. I look into this.

[tango65]

Consult about premedications with anti allergics and tylenol because of the acute phase reaction

"Acute Phase Reaction

Within three days after Zoledronic Acid Injection administration, an acute phase reaction has been reported in patients, with symptoms

including pyrexia, fatigue, bone pain and/or arthralgias, myalgias, chills, and influenza-like illness. These symptoms usually resolve within a

few days. Pyrexia has been the most commonly associated symptom, occurring in 44% of patients"

accessdata.fda.gov/drugsatf...

Consult about taking celebrex or NSAIDS since zoledronic acid may affect the kidneys

"Renal Toxicity

Administration of Zoledronic Acid Injection 4 mg given as a 5-minute intravenous infusion has been shown to result in an increased risk of renal

toxicity, as measured by increases in serum creatinine, which can progress to renal failure. The incidence of renal toxicity and renal failure has

been shown to be reduced when Zoledronic Acid Injection 4 mg is given as a 15-minute intravenous infusion. Zoledronic Acid Injection should

be administered by intravenous infusion over no less than 15 minutes [see Warnings and Precautions (5.3), Dosage and Administration (2.4)].

The most frequently observed adverse reactions were fever, nausea, constipation, anemia, and dyspnea (see Table 4)."

[Maxone73 in reply to tango65]

correct, I do a 25 minutes IV for 4mg

[NewPotatoCaboose in reply to tango65]

I'm scheduled for 5mg over 30 minutes for next month.

[Lion321 in reply to NewPotatoCaboose]

Wishing you all the best for your infusion. Please if you feel able to share your experience in the future it would be a great help.

Thank you.

[NewPotatoCaboose in reply to Lion321]

Will do!

[Lion321 in reply to tango65]

Thank you so much for your reply very informative and very helpful. Thank you.

[tango65 in reply to Lion321]

Best of luck with the treatment.

[Lion321 in reply to tango65]

Thank you

[Anon2014]

there is a significant risk (~20% if I recall correctly) of getting osteonecrosis of the jaw (ONJ) with intravenous infusions of Zoledronic Acid. It happened to me.

[Lion321 in reply to Anon2014]

So sorry to hear that. I am completely in the dark regarding this If you don’t mind explaining what happens to your jaw how it affects you and can you cure it.

Many thanks for sharing your information on this subject can help so many people.

Thank you.

[Anon2014 in reply to Lion321]

As I understand it, the ONJ happens because the jawbone gets infected. My ONJ was caught via annual dental X-rays after the 3rd or 4th infusion. I had to go to an oral surgeon to have it treated. The surgeon had to pull the molar near the ONJ, drill out the infected jawbone area, insert cadaver bone (used as scaffolding in the healing process), then suture it closed. I had to use a prescription mouthwash several times a day for weeks.

Backing up a bit, about 3-6 months (too long ago to remember more precisely) prior to starting ZA (Zometa) I had a root canal done on the tooth that had to be pulled so it may be I needed to wait longer before starting the ZA. Unfortunately I didn’t do research on Zometa until after I started the monthly infusions. FYI, neither the prescribing oncologist nor the nurse administering the infusions ever told me about the risks (what to be on the lookout for) nor asked if I was having any jaw issues…so it’s good you’re researching first.

[Lion321 in reply to Anon2014]

So sorry about your experience really appreciate you sharing it. You have helped so many people by letting them know what could happen if they were in the same situation as you. You can read lots of different advice but your advice is on from experience.

Thank you so much

[Anon2014 in reply to Lion321]

On the other hand, I now (6 years later) have osteoporosis in vertebrae L1 thru L4. Oncologist says don’t lift more than 7 lbs, no running/jogging, and no falling otherwise I may get compression fractures in those vertebrae.

Pick your poison…

[Lion321 in reply to Anon2014]

Sorry to hear your in the same boat as me. Has your oncologist not mentioned the Zoledronic acid to help your bones? Or physiotherapist ?

[Anon2014 in reply to Lion321]

Zometa is a Zoledronic acid (ZA)

[Grandpa4 in reply to Anon2014]

I don’t think infection is involved causally. I think the bone dies and then sometimes gets infected. It is more common at the doses they use on cancer patients but can happen at normal doses as well.

[Atdabeach]

I fear that the comments above might create some confusion for others. I assume the OP is being prescribed zoledronic acid to treat the bone density issue that led to fractures, not as a primary treatment for PCa. I too had fractures, which my doctors attributed to a combination of reduced bone density due to ADT and radiation damage to my lower spine from my proton beam therapy. In my case it was sacral insufficiency fractures, along with fractures to the S2 vertebral body. I had also had a bone density (DEXA) scan, which indicated osteopenia. They prescribed Reclast (one of several brand names for zoledronic acid), which I received in an infusion taking about half an hour. I understand I will be getting it once a year going forward. Before getting the go-ahead for the infusion, I needed clearance from my dentist, and lab tests for calcium levels (blood and urine), parathyroid hormone, c-telopeptides, and vitamin D.

The fractures were discovered when I had an MRI due to extremely painful sciatica. With a combination of the Reclast infusion, calcium supplements, and rest, I got much better over a period of 1-2 months. I'm now back to full workouts with my trainer 2x/week (yes, I know I should do more), and walking daily. Zoledronic acid was a miracle drug for me.

[Lion321 in reply to Atdabeach]

Thank you so much for your positive reply. I am so worried about it with all the negative side effects kidney, liver etc. you have given me hope. Thank you.

[MateoBeach]

My bias is to start intensive bone protection regimen early, before bone Mets or even osteoporosis if possible. Bone Mets with fractures and severe pain are in the end stage for MCRPC for 90%. If there is a chance to get ahead and. Even possibly alter the bone micro environment then I choose to take it. Either ZA or denosumab. Don’t wait. It is a one way street.

[skiingfiend in reply to MateoBeach]

I'm not so sure this is a good idea. Don't take drugs you don't need. Your doctors will advise you when you need to start taking these drugs based on your status. Also AE's like ONJ become more likely the longer you take these drugs so you need to balance the good vs the bad.

My specialist told me that Denosumab will add back 5% bmd on average in the first year and 2% per year after that.

If I was to follow your strategy and I was not osteopenia or osteoporosis I would look at oral bisphosphonates first based on their mechanism of action.

[85745]

From all I read vit k2 (mk -7 ) recommend taken along with calcium or vit D . Research Fermented Sauerkraut has vit C and K2 good for gut pre and pro biotics. Also read some people cannot absorb vit D and calcium properly. Maybe ck out Dr. Berg videos on this subject matter. Best

[addicted2cycling in reply to 85745]

I take D3/K2 liquid sub-lingually + eat Cleveland KRAUT various varieties in the refrigerated section + SO UNSWEETENED coconutmilk a yogurt alternative with lots of Organic Ceylon cinnamon

Was prescribed Alendronic acid due to DEXA results showing osteoporosis and osteopenia but have refused to take it.

[85745 in reply to addicted2cycling]

Yes I buy Cleveland kraut and their Kimchi also, get it at Walmart decent price comparison. These prescribed meds overtime I read can raise some issues, but they always seem to have the fix, Old saying it's baked in the cake. lol . I just don't know what to think with all these meds. my zero co pay runs out in 2 mo on a ADT they just put me on and I told them why bother I can't afford the out of pocket. crickets . Thanks, Best

[addicted2cycling in reply to 85745]

Orchiectomy for me so no ADT charge$ 👍😀 for almost 9 years now. Walmart here stopped carrying the Kraut so have to pay extra at Publix.

[85745 in reply to addicted2cycling]

I hope and pray for 9more, keep on !

[addicted2cycling in reply to 85745]

Working on it but Pylarify PSMA PET 2 weeks ago showed a return in remaining left half. Will have Dr. Onik's 3D Prostate MAPPING Biopsy to see what's there and in the interim getting out busting my ass with 40+ mile bicycle rides. Happily rode 44 miles today and managed to hit 27.4mph very briefly.Just have to keep on keeping on the best one can.

Good luck 👍👍

[85745 in reply to addicted2cycling]

Thanks, wish you the best. 40+ miles ! nice

[addicted2cycling in reply to 85745]

THANKS -- Finally getting back to feeling comfortable on my bikes after 2020 and 2022 being hit by a couple of wild hogs while riding and a couple of crashes. Hopefully by birthday 74 in July I'll be back to 100 mile Birthday Ride.

[addicted2cycling]

SO sorry but NO Jalapeno only Ghost Peppers and a shot of Ironroot Republic's Straight Corn Whiskey 133.7😱 Proof for her is on me.

[skiingfiend]

Look into denosumab.

Whether it is ZA or D, you are on this for life now.

D is better or no worse than ZA on all meaningful metrics except cost.

So if cost is no object, D is the way to go.

Additionally D is a simple injection vs ZA which is an infusion.

Here is the specialist I saw for my osteoporosis and he strongly recommended D over all other options.

vchri.ca/researchers/david-...