Interesting side effect to Prolia

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For those with osteoporosis and trying to decide on which drug to cho, Prolia may have a second reason for choosing it.
Denosumab (Prolia) Protective Against Diabetes?

Denosumab Protective Against Diabetes?
— Study found lower diabetes incidence with osteoporosis drug for patients who stayed on treatment
by Kristen Monaco, Senior Staff Writer, MedPage Today February 13, 2024

Continued treatment with the osteoporosis drug denosumab (Prolia) was tied to a lower risk of developing diabetes in a Taiwanese cohort study.
In a propensity score-matched analysis, adherence to denosumab for osteoporosis was associated with a 16% lower risk for incident diabetes compared with cessation after the first dose (HR 0.84, 95% CI 0.78-0.90), Edward Chia-Cheng Lai, PhD, of National Cheng Kung University in Taiwan, and colleagues reported in JAMA Network Open

Stratification by age, however, showed the findings to be entirely driven by patients 65 and up:

  • Age 65 and over: HR 0.80 (95% CI 0.75-0.85)
  • Younger than 65 years: HR 1.02 (95% CI 0.83-1.27)
The findings, which had an average follow-up of just under 2 years, suggest a potential dual benefit with denosumab in this population, Lai told MedPage Today, combining the agent's established role in preventing bone fractures with the potential protection against diabetes.

"This is particularly significant given the increasing prevalence of both osteoporosis and diabetes in the aging population," Lai said. "Our study suggests that when choosing anti-osteoporosis medication, physicians might also consider the potential benefit of lowering diabetes risk. This could be especially relevant for patients at high risk of diabetes or those with preexisting metabolic conditions."

While promising, the findings weren't entirely surprising, he added. "Given the preclinical evidence suggesting that receptor activator of nuclear factor κB ligand (RANKL) signaling inhibition can improve insulin sensitivity and glucose tolerance, we hypothesized that denosumab could have a positive impact on glucose homeostasis," Lai explained. "It's rewarding to see clinical data align with preclinical expectations, reinforcing the potential for osteoporosis treatments to have broader metabolic benefits."

"We hope doctors will recognize the importance of considering the broader health implications of anti-osteoporosis treatments," said Lai.

Denosumab was first approvedopens in a new tab or window back in 2010 for postmenopausal women with osteoporosis at high risk for bone fracture. The RANKL inhibitor later picked up a number of other indications, including osteoporosis in men, glucocorticoid-induced osteoporosis in either sex, bone loss in men receiving androgen-deprivation therapy for prostate cancer, and bone loss for women receiving aromatase inhibitor therapy for breast cancer. But following an FDA safety alertopens in a new tab or window in November 2022, the agency recently added a boxed warningopens in a new tab or window to the label over the risk of severe hypocalcemia in patients with advanced chronic kidney disease.

Denosumab is also approved under the trade name Xgeva to reduce the risk of bone-related events in certain cancer patients.

A total of 68,510 patients were included in the nationwide, propensity score-matched cohort study. Patient data came from Taiwan's National Health Insurance Research Database on adults who received denosumab for osteoporosis from 2012 to 2019. Most were female (84.3%) and the average age was 78 years.

The treatment group included 34,255 patients who received their second dose per the anticipated administration schedule 180 days after the initial dose, and the comparison group included 34,255 patients who didn't receive a second dose.

Half of the patients in each group had a history of vertebral fracture, 15% had a history of hip fracture, and 5% had a history of wrist or humerus fracture.

Incident diabetes was defined as need for a new antidiabetic drug. Over a mean 1.9 years of follow-up, a total of 2,016 denosumab-treated adults developed diabetes versus 3,220 of those who stopped treatment (incidence rates of 35.9 vs 43.6 per 1,000 person-years, respectively).

The lower risk of diabetes associated with denosumab was consistent across sexes and seen regardless of comorbidity status: with or without dyslipidemia, with or without hypertension, with or without ischemic heart disease, and with or without kidney failure.

Other factors such as lifestyle, substance use, prediabetes status, weight, and lab results weren't available for the patients.
 
I mentioned this during my endocrinologist appointment today. He hadn’t seen it yet but was going to find it. He did remind me that once on Prolia, you stay on Prolia for life. I said I was aware but I was coming to the end of my time with my using Reclast and my osteoporosis specialist offered me the opportunity to use it or switch to Prolia. I chose the one more round of Reclast but will tell her based on this new information, I will switch to Prolia when it’s time for me to switch.
 
I mentioned this during my endocrinologist appointment today. He hadn’t seen it yet but was going to find it. He did remind me that once on Prolia, you stay on Prolia for life. I said I was aware but I was coming to the end of my time with my using Reclast and my osteoporosis specialist offered me the opportunity to use it or switch to Prolia. I chose the one more round of Reclast but will tell her based on this new information, I will switch to Prolia when it’s time for me to switch.
What happens when you stop Prolia. I’ve started and stoped Prolia twice during a 3 year period.
 
What happens when you stop Prolia. I’ve started and stoped Prolia twice during a 3 year period.
It can lead to fractures. They are not saying it will but that it can. And if you stop, you should be on another treatment plan.

At almost 70, I’m okay with being on it long term. Long term for me could be anywhere from a day to 30 plus years.
 
Does prolia fall under Part D of Medicare? If so, do any of the plans cover it well or at least a good portion? My last Dexa wasn’t too great.
 
I have decided that:
Those who take Prolia, will then need to follow up with another drug; and,
They ALL “threaten” my existing medical issues; and,
Taking any of them may help bones but cause other problems.

IOW, I ALREADY supplement Calcium and Vit D and fight like crazy to stay in range. Taking a drug that would CAUSE deficiencies might not be a good idea. Plus GI side effects? I’m already there, too.

https://www.goodrx.com/conditions/osteoporosis/fosamax-vs-prolia-vs-boniva#
 
I take calcium and D and fight like crazy to stay in range but genetics had other ideas.

So far, there isn’t an end date on Prolia, officially.

“Osteoporosis is a chronic condition that generally requires long-term monitoring and therapy. Even though the maximum follow-up time for published clinical data on the long-term effects of denosumab treatment is 10 years, there is no absolute limit on treatment duration [31]. In some patients at continued high risk for fracture, treatment with denosumab should be continued indefinitely.”
 
I have decided that:
Those who take Prolia, will then need to follow up with another drug; and,
They ALL “threaten” my existing medical issues; and,
Taking any of them may help bones but cause other problems.

IOW, I ALREADY supplement Calcium and Vit D and fight like crazy to stay in range. Taking a drug that would CAUSE deficiencies might not be a good idea. Plus GI side effects? I’m already there, too.

https://www.goodrx.com/conditions/osteoporosis/fosamax-vs-prolia-vs-boniva#
I started with Boniva injection and had a reaction- it caused high parathyroid with low calcium which resulted in extreme depression, fatigue, and other side effects. My calcium levels were good before the injection. Next, Prolia was attempted. My calcium levels were normal and vitamin d was good. They checked my parathyroid levels also and they were normal. Within a few days after the Prolia injection, the same side effects hit, but were more severe. I could barely function and it took several months to get levels back to a normal range. The depression was so severe that I told doctors I wouldn’t try again, not to mention that I was required to have the injection at the hospital because the doctor wouldn’t do it in office so the bill was $9,000. My copay was $900. They have now discovered that I’m losing calcium from my kidneys, so that’s likely the reason for my reactions. If possible before starting those medications, you may want to request a blood calcium AND a 24 hour urine calcium first. Good luck!
 
My new rheumatologist about had a fit saying oral alendronate is not appropriate for anyone with any malabsorption issues and ordered a new DEXA.
After 2.5 miserable years on Fosamax (alendronate) I had slightly worse scores on the bone density test and have started on Prolia.
 
Not anything technical but I had a good laugh reading a message my hearing impaired DH took down. He wrote down that my endocrinologist's office called to confirm my appointment and something about a polio shot. I'm thinking, "What? Wasn't polio eradicated in the 60's? And why would they want to give me a polio shot? They didn't. They called about my next Prolia injection. Life has always been an adventure, but his hearing loss has been a constant source of confusion and amusement.
 
Not anything technical but I had a good laugh reading a message my hearing impaired DH took down. He wrote down that my endocrinologist's office called to confirm my appointment and something about a polio shot. I'm thinking, "What? Wasn't polio eradicated in the 60's? And why would they want to give me a polio shot? They didn't. They called about my next Prolia injection. Life has always been an adventure, but his hearing loss has been a constant source of confusion and amusement.
Oh Lordy, that would make for some interesting conversations.
 
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