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Bone Loss after Denosumab?
According to the article below, bone loss after denosumab discontinuation is a problem. But continuing denosumab forever increases the risk of side effects particularly ONJ. And this expensive drug many not be covered by your health insurance forever…
MM can cause bone loss. Stoping denosumab causes bone loss. Continuing denosumab forever causes side effects.
What does the MM patient do?
All newly diagnosed multiple myeloma (NDMM) patients are prescribed the FDA approved standard-of-care therapy plan which includes a bone strengthening drug- either a bisphosphonate like aredia or zometa or denosumab. Research has shown that both of these therapies reduce the risk of “skeletal-related events” aka fractures. NDMM patients are often at risk of bone fractures because of MM forming lesions in their bones.
The study linked below calls into question long-term use of denosumab therapy. If the MM patient discontinues this therapy, their bones may thin. Unfortunately, denosumab (prolia) can cause a number of short and long-term side effects.
BTW, has anyone’s oncologist ever talked to them about the “the potential risks associated with discontinuing the medication…” as the doctor comments below?
Is it safe to stop Xgeva (denosumab)?
As a long-term MM patient I have to say that NDMM patients may benefit from the bone strengthening that denosumab can provide. As the study below explains, stopping denosumab or continuing it long-term can be problematic. Perhaps denosumab should be a short-term solution?
I think that evidence-based non-conventional bone health therapies such as:
- exercise
- nutrition
- supplementation
should all be considered immediately upon diagnosis of MM if possible. Of course it makes sense to discuss this with your oncologist.
Email me at David.PeopleBeatingCancer@gmail.com to discuss your bone health.
Hang in there,
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
How to Stop Bone Loss After Denosumab? No Easy Answers
“Patients who discontinue treatment with the osteoporosis drug denosumab, despite transitioning to zoledronate, show significant losses in lumbar spine bone mineral density (BMD) within a year, according to the latest findings to show that the rapid rebound of bone loss after denosumab discontinuation is not easily prevented with other therapies — even bisphosphonates.
“When initiating denosumab for osteoporosis treatment, it is recommended to engage in thorough shared decision-making with the patient to ensure they understand the potential risks associated with discontinuing the medication…”
The results are from the Denosumab Sequential Therapy prospective, open-label, parallel-group randomized clinical trial, published online on November 11 in JAMA Network Open.
In the study, 101 patients were recruited between April 2019 and May 2021 at a referral center and two hospitals in Taiwan. The patients, including postmenopausal women and men over the age of 50, had been treated with regular denosumab for at least 2 years and had no previous exposure to other antiosteoporosis medication.
They were randomized to treatment either with continuous denosumab at the standard dose of 60 mg twice yearly or to discontinue denosumab and receive the standard intravenous dose of the bisphosphonate zoledronate at 5 mg at the time when the next dose of denosumab would have been administered.
There were no differences between the two groups in serum bone turnover markers at baseline.
The current results, reflecting the first year of the 2-year study, show that, overall, those receiving zoledronate (n = 76), had a significant decrease in lumbar spine BMD, compared with a slight increase in the denosumab continuation group (−0.68% vs 1.30%, respectively; P = .03).
No significant differences were observed between the groups in terms of the study’s other measures of total hip BMD (median, 0% vs 1.12%; P = .24), and femoral neck BMD (median, 0.18% vs 0.17%; P = .71).
Additional findings from multivariable analyses in the study also supported results from previous studies showing that a longer duration of denosumab use is associated with a more substantial rebound effect: Among 15 of the denosumab users in the study who had ≥ 3 prior years of the drug, the reduction in lumbar spine BMD was even greater with zoledronate compared with denosumab continuation (−3.20% vs 1.30%; P = .003)…
Fracture Risk Is the Overriding Concern
Meanwhile, the loss of lumbar spine BMD is of particular concern because of its role in what amounts to the broader, overriding concern of denosumab discontinuation — the risk for fracture, Fu noted.
“Real-world observations indicate that fractures caused by or associated with discontinuation of denosumab primarily occur in the spine,” he explained…
“I think denosumab is a very good treatment for some patients with high fracture risk and very low BMD, but both patients and clinicians should know that this treatment is either lifelong or there needs to be a plan for discontinuation,” Langdahl said…
But until then, “I think [cost] should be considered before starting treatment because if patients cannot afford denosumab, they should have been started on zoledronate from the beginning…”
Though reported as being rare, research continuing to stir concern for ONJ with denosumab use includes one recent study of patients with breast cancer showing those treated with denosumab had a fivefold higher risk for ONJ vs those on bisphosphonates.
“About 20% of my patients have ONJ concerns or other questions, which may delay treatment with denosumab or other therapies,” Hofbauer told Medscape Medical News.
“There is a high need to discuss risk versus benefits towards a shared decision-making,” he said…