Hello Friends. During my last appt with my MO, he told me that I would no longer be receiving Zometa for my bones (after 4 infusiones every 3 months). I have bone metástasis throughout my body and lift wts and run every day, so this worrys
me. He insists that the protocol is just 4 infusiones for life. Any insights on this?
No the Zometa protocol from the manufacturer is not 4 infusions for life, although that may be his own personal protocol. Some oncologists like to give a break after 3 years or so because side effects are cumulative. It should not be used if a DEXA scan does not indicate a need for it. If you have been running and lifting weights for a while, your bone mineral density may be higher than average, and you may not require it at all.
Thanks TA
How long Zometa or any other bone builder is required should be calculated based on your DEXA scan's T score and Z score.
Then the DEXA scores to be put in FRAX calculator( fracture risk calculator) to finally decide if you still need Zometa. Blindly giving Zometa continuously does invite serious side effects.
Thanks Learnall. I am in the public health system in El Salvador, so I don, t have much flexibility. I know nothing of the options you propose - the cost of residing in the 3rd World.
No insights on the Zometa, but have you or your doc considered low-dose estrogen patch or gel, to address some of the bad effects of ADT and loss of estrogen (which include bone loss)?
Will check on this. Thanks.
Since you have many bone metastases I think this information may be important .
Anti Reabsorption bone therapy is given to treat osteopenia caused by ADT, but they are also given to avoid skeletal related events (pain, fractures, spinal cord compressions etc) in castration resistant cancer with bone metastases.
This is some information from UP to Date:
""Duration of therapy (castration resistant cancer) — The optimal duration of monthly therapy with an osteoclast inhibitor for prevention of SREs is not established. The pivotal trials treated patients for a maximum of 24 months [1,29,37]. The incidence of jaw osteonecrosis has been higher with longer duration of therapy [39]. Because of this, many clinicians, including some of the authors and editors associated with this topic, discontinue osteoclast inhibitors after 12 doses. (See "Medication-related osteonecrosis of the jaw in patients with cancer", section on 'Osteoclast inhibitor therapy'.)""
More info:
""Prevention of skeletal-related events
Castration-resistant disease — In men with bone-metastatic castration-resistant prostate cancer (CRPC), we recommend the use of a bone-modifying agent to prevent or delay skeletal-related complications. For most patients, we suggest denosumab rather than zoledronic acid, based on superior efficacy in a large randomized trial. If cost and/or reimbursement are important considerations, zoledronic acid is an appropriate alternative. Both agents should be administered at bone metastasis-indicated doses (denosumab 120 mg subcutaneously every four weeks, zoledronic acid 4 mg intravenous infusion every three to four weeks). This recommendation is consistent with guidelines from CCO and ASCO [1,2].
If zoledronic acid is chosen, there are sufficient data in men with CRPC to support dosing of zoledronic acid every 12 weeks rather than every 4 weeks for most men. We still prefer every-four-week dosing, at least initially, for patients who have extensive or highly symptomatic bone metastases, including all patients who are receiving Ra-223. (See "Osteoclast inhibitors for patients with bone metastases from breast, prostate, and other solid tumors", section on 'Dosing interval'.)
Bisphosphonates — In men with CRPC and bone metastases, bisphosphonates delay the development of SREs, which is a composite endpoint that includes pathologic fractures, RT to bone, surgery to bone, and spinal cord compression. The approved dose for zoledronic acid is 4 mg intravenous every three to four weeks. There are now sufficient data in men with CRPC to support dosing of zoledronic acid every 12 weeks rather than every 4 weeks for most men. We still prefer every-four-week dosing, at least initially, for patients who have extensive or highly symptomatic bone metastases, including all patients who are receiving Ra-223. (See "Osteoclast inhibitors for patients with bone metastases from breast, prostate, and other solid tumors", section on 'Dosing interval'.)
The benefit of zoledronic acid in men with bone metastases and CRPC was demonstrated in a trial in 643 men whose disease was progressing while on ADT [29]. Men were randomly assigned to one of two doses of zoledronic acid (4 or 8 mg) or placebo, each given every three weeks. The 8-mg dose of zoledronic acid was reduced to 4 mg early in the trial because of an increased risk of renal toxicity.
At a follow-up of 24 months, there was a significant decrease in the frequency of SREs with zoledronic acid compared with placebo (38 versus 49 percent), and the median time to develop an SRE was significantly longer with zoledronic acid (488 versus 321 days) [30]. Pain and analgesic scores were significantly lower in men who received zoledronic acid compared with placebo, but there were no differences in disease progression, performance status, or quality-of-life scores among the groups.
Zoledronic acid is approved in the United States for use in men with CRPC and bone metastases. The European Committee for Proprietary Medicinal Products has approved zoledronic acid for all men with bone metastases from prostate cancer.
The approved dose and schedule of administration for zoledronic acid are 4 mg every three to four weeks, with the dose adjusted for creatinine clearance. However, there are sufficient data in CRPC to support less frequent dosing (every 12 weeks rather than every 4 weeks), and we suggest this approach for most patients. A 2017 focused guideline update on the role of osteoclast inhibitors in metastatic breast cancer from ASCO and CCO also supports every-12-week dosing as an alternative to monthly therapy [36]. Some may prefer to initiate therapy with every-four-week dosing for patients with metastatic CRPC until the bone disease is stabilized. (See "Osteoclast inhibitors for patients with bone metastases from breast, prostate, and other solid tumors", section on 'Dosing interval'.)
Denosumab (Prolia, Xgeva)— Denosumab is a fully humanized monoclonal antibody that binds to the RANK ligand, a key factor in the pathway for osteoclast formation and activation. (See "Denosumab for osteoporosis" and "Mechanisms of bone metastases", section on 'RANK/RANKL signaling pathway and bone remodeling'.)
Denosumab has been evaluated in a range of clinical settings. Denosumab is approved for the prevention of SREs in men with prostate cancer bone metastases and for the treatment of bone loss in men receiving ADT.
Denosumab is more effective than zoledronic acid in preventing SREs in men with established bone-metastatic CRPC, although it does not improve overall survival or time to disease progression.
In a double-blind phase III trial, 1901 men with CRPC and at least one bone metastasis were randomly assigned to denosumab (120 mg) or zoledronic acid (4 mg), each given every four weeks [37]. Patients on both treatment arms were advised to use calcium and vitamin D supplements. The primary objective of the study was time to first SRE (pathologic fracture, need for RT or surgery, or spinal cord compression).
At a median follow-up of approximately 12 months, results included the following:
●The time to first SRE was significantly delayed with denosumab compared with zoledronic acid (median 20.7 versus 17.1 months, hazard ratio [HR] 0.82, 95% CI 0.71-0.95).
●There was no statistically significant difference in either overall survival (19.4 versus 19.8 months, HR 1.03) or time to disease progression (8.4 months with both regimens, HR 1.06).
●Both treatments were well tolerated. Osteonecrosis of the jaw trended toward being more frequent with denosumab compared with zoledronic acid (2.3 versus 1.3 percent), although these differences were not statistically significant. Hypocalcemia was also significantly more frequent with denosumab (13 versus 6 percent).
Castration-sensitive disease — Osteoclast inhibitors are not indicated in men with bone metastases and castration-sensitive prostate cancer.
In contrast to the results in men with castration-resistant disease, no benefit was seen when zoledronic acid was started during initial treatment with ADT in men with bone metastases. In the CALGB 90202 trial, 645 men were randomly assigned to zoledronic acid or placebo [40]. The trial was discontinued prematurely when the corporate sponsor withdrew support. With a median follow-up of 24 months, there was no statistically significant difference in the time to first SRE (median 31.9 versus 29.8 months, HR 0.97). Overall survival also was not significantly different (median 38 versus 36 months, HR 0.88, 95% CI 0.70-1.12).
There are no data on denosumab for the prevention of SREs in patients with castration-sensitive disease. Published guidelines from CCO and ASCO state that there is insufficient evidence to make a recommendation regarding the use of bone-modifying agents in men with bone metastases and castration-sensitive prostate cancer [1,2].
Prevention or delay of bone metastases — Randomized trials with both bisphosphonates and denosumab have failed to demonstrate a favorable risk-benefit ratio for men with nonmetastatic CRPC. We recommend against the use of these agents to prevent or delay the appearance of bone metastases in men with high-risk nonmetastatic prostate cancer, a position that is consistent with guidelines from CCO and ASCO [1,2]. ""
Thanks so much Tango 65 for all of this pertinente detail.
Best of luck on this journey.
Thank you Tango65 - my Dad has been on Xgeva for several years and I greatly appreciate this information/clarification!
Best of luck on this journey.!
Hi, my dad has one bone met on his pubic bone but quite a few distant lymph node mets. His MO got him on 3 monthly zometa infusions but for one reason or the other he has not been able to take them timely. The reasons being:
- Dental work to be done
- Was schedule to travel abroad during the scheduled zometa infusion
- Covid-19 lockdown and the doctor advised not to come to the hospital for it
I had raised my concerns to the MO whether it is okay to miss these doses, the MO assured me it is absolutely okay and many of his patients even stop them after a year. The infusion is for bone strengthening and used as a precautionary measure to help with the side effects of ADT and old age, but it does not come without its own side effects - so a balance has to be maintained between the two. The same is determined keeping many parameters in mind and differs from patient to patient, just like some people take monthly doses whereas some take quarterly. In my dad's case he said its okay if he does not take them and mentioned about his alkaline phosphate levels being normal and within range.
Should I try Zometa for Castrate sensitive Bone mets on ADT
Zometa
Dental extraction while on Zometa
Zometa side effects on Lupron
When should you start taking Bisphosphonates, or bone strengthening medications.
