bisphosphonates Update by FDA

Posted by bone9lady @bone9lady, Apr 4 12:03pm

I have been on and off Fosamax for several years. As of Feb. 2026, the FDA has updated the safety labels for bisphosphonate medications to include a warning that atypical fractures can occur in bones other than the femur. These include the ulna (arm) and tibia (lower leg). The updated warning includes fosamax, reclast, actenol, Boniva. The warning is for those on bisphosphonates longer than 5 years. I just happen to come upon the update or I wouldn't have been aware of it. I'll be discussing it with my endocrinologist. There is no need to panic but knowledge is everything!

Interested in more discussions like this? Go to the Osteoporosis & Bone Health Support Group.

I started alendronate once a week about 3 months ago and seem to be more uncomfortable and more joint pain than before. Is this normal? And if there are warnings about fractures while on it, is it really worth it to take this drug? I guess I really don’t understand why not just increase calcium intake to try to improve bone density.

REPLY
Profile picture for gracierose @gracierose

I started alendronate once a week about 3 months ago and seem to be more uncomfortable and more joint pain than before. Is this normal? And if there are warnings about fractures while on it, is it really worth it to take this drug? I guess I really don’t understand why not just increase calcium intake to try to improve bone density.

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@gracierose This website lists joint pain as a side effect of Fosamax: https://www.goodrx.com/alendronate/common-side-effects

My Dr prescribed Fosamax and I declined because I've read that, although it reduces bone breakdown it also reduces formation of new bone. Studies show bisphosphonates offer minimal benefits at fracture prevention, and isn't that the point of taking any bone drugs?

Here are a couple studies on the "absolute risk" vs benefit of bisphosphonates: https://www.amjmed.com/article/S0002-9343(24)00101-3/fulltext
From that study: "When the baseline risk is low, use of relative risk alone is likely misleading. According to the review conducted by the ACP, the relative risk reduction of hip fractures with bisphosphonate treatment for at least 3 years is 36%; however, the absolute risk reduction is only 0.6%. Framed as number needed to treat, 167 patients need to be treated for 3 years to prevent one hip fracture."
"The benefits of treatment in older or less functional adults are less certain, as clinical trials mostly excluded adults over age 80 and residents of long-term care facilities; limited data in both subgroups does not support a fracture risk reduction. In addition, the long-term benefits of fracture risk reduction must be considered in the context of functionality and life expectancy. The time to benefit for bisphosphonates is estimated to be 1-2 years for important clinical outcomes like hip fracture and vertebral fractures."

Another study:
https://www.consumerreports.org/cro/2012/04/popular-osteoporosis-drugs-come-with-mounting-concerns/index.htm
"Bottom line. Bisphosphonates offer only modest benefits in building bone and preventing fractures, and that should be considered along with the risks.”

I recently posted a discussion on the benefits of taking high doses of Vitamin K for osteoporosis. You can look for it under this support group.

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What scares me is that we don't really have an FDA like we used to (we have one in name only). You don't know what is true and what isn't. I have been told one should rely on sources from medical sources in other countries. I would probably believe sources like Mayo Clinic or Cleveland Clinic. The AMA is still supposed to be a reliable source. I don't really trust information coming from US sources from the last couple of years, certainly not FDA or CDC. Just my opinion.

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Profile picture for daisy17 @daisy17

@gracierose This website lists joint pain as a side effect of Fosamax: https://www.goodrx.com/alendronate/common-side-effects

My Dr prescribed Fosamax and I declined because I've read that, although it reduces bone breakdown it also reduces formation of new bone. Studies show bisphosphonates offer minimal benefits at fracture prevention, and isn't that the point of taking any bone drugs?

Here are a couple studies on the "absolute risk" vs benefit of bisphosphonates: https://www.amjmed.com/article/S0002-9343(24)00101-3/fulltext
From that study: "When the baseline risk is low, use of relative risk alone is likely misleading. According to the review conducted by the ACP, the relative risk reduction of hip fractures with bisphosphonate treatment for at least 3 years is 36%; however, the absolute risk reduction is only 0.6%. Framed as number needed to treat, 167 patients need to be treated for 3 years to prevent one hip fracture."
"The benefits of treatment in older or less functional adults are less certain, as clinical trials mostly excluded adults over age 80 and residents of long-term care facilities; limited data in both subgroups does not support a fracture risk reduction. In addition, the long-term benefits of fracture risk reduction must be considered in the context of functionality and life expectancy. The time to benefit for bisphosphonates is estimated to be 1-2 years for important clinical outcomes like hip fracture and vertebral fractures."

Another study:
https://www.consumerreports.org/cro/2012/04/popular-osteoporosis-drugs-come-with-mounting-concerns/index.htm
"Bottom line. Bisphosphonates offer only modest benefits in building bone and preventing fractures, and that should be considered along with the risks.”

I recently posted a discussion on the benefits of taking high doses of Vitamin K for osteoporosis. You can look for it under this support group.

Jump to this post

@daisy17 I read in a medical white paper years ago, might still have it somewhere that bisphosphonates take bone cells from the femur to strengthen the pelvis and hips and that it stays on your body continueing to do this for 10 years after you stop taking it.
In 2014 at the age of 57 I had the bones of a 70 year old shown in DXA scan. That went untreated until 2016 due to original doctor leaving praxctice and the ball got dropped.
I began Fosomax (Alendronate) in 2016 thru 2019 until gut issues got so bad I had to stop.
I exercised, took bone supplements and a fairly healthy diet. no bone meds after 2019.
In Jan 2026 I tripped and fell and broke my femur. It snapped like a dry branch in midfall, not when I hit the ground.
Titanium Rod installed. I blame the bisphosphonates based on the white paper I researched years ago.
That's my opinion based on my personal experience only. Take that for what you will for anyone reading this.
Post surgery research I also discovered the warning signs of an impending femur break. I had them, hindsight being what it is. I just wrote it off to arthritic pains when walking. Femural Bone pain and joint pain in the hip.

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Profile picture for inlimbo @inlimbo

@daisy17 I read in a medical white paper years ago, might still have it somewhere that bisphosphonates take bone cells from the femur to strengthen the pelvis and hips and that it stays on your body continueing to do this for 10 years after you stop taking it.
In 2014 at the age of 57 I had the bones of a 70 year old shown in DXA scan. That went untreated until 2016 due to original doctor leaving praxctice and the ball got dropped.
I began Fosomax (Alendronate) in 2016 thru 2019 until gut issues got so bad I had to stop.
I exercised, took bone supplements and a fairly healthy diet. no bone meds after 2019.
In Jan 2026 I tripped and fell and broke my femur. It snapped like a dry branch in midfall, not when I hit the ground.
Titanium Rod installed. I blame the bisphosphonates based on the white paper I researched years ago.
That's my opinion based on my personal experience only. Take that for what you will for anyone reading this.
Post surgery research I also discovered the warning signs of an impending femur break. I had them, hindsight being what it is. I just wrote it off to arthritic pains when walking. Femural Bone pain and joint pain in the hip.

Jump to this post

@inlimbo You are correct that bisphosphonates can remain in the bone for 10 years or so, but I don't think those drugs take bone cells from the femur. The attached explains that these drugs slow the shedding of old bone, and also slow the rebuilding of newer bone, leaving bone that can be more brittle than newer bone. That is why some studies show that the bones may appear more dense on a DEXA scan, but offer minimal benefits of fracture prevention.

From the article: "bisphosphonates’ main function: slowing the resorption (shedding) of old bone, which is typically followed by remodeling, the growth of new bone. In healthy adults, cortical bone is constantly being resurfaced, such that the entire adult skeleton is overhauled every 10 years or so.

But that resurfacing process begins with resorption, and if resorption is slowed by bisphosphonates, the remodeling process is also affected. The result: The existing bone ages and gets brittle over time. “It’s kind of a double-edged sword. It’s extremely good to prevent bone loss, but the drugs will also slow this natural process, which allows turnover.”

The other unforeseen side effect to long-term bisphosphonate use involves crack-deflection—the resurfaced bone’s ability to stop a microscopic crack from propagating, which can lead to a break. New layers of bone can act as a “firewall” of sorts, stopping a crack from spreading, but mineralized, older bone loses that function."

REPLY
Profile picture for daisy17 @daisy17

@inlimbo You are correct that bisphosphonates can remain in the bone for 10 years or so, but I don't think those drugs take bone cells from the femur. The attached explains that these drugs slow the shedding of old bone, and also slow the rebuilding of newer bone, leaving bone that can be more brittle than newer bone. That is why some studies show that the bones may appear more dense on a DEXA scan, but offer minimal benefits of fracture prevention.

From the article: "bisphosphonates’ main function: slowing the resorption (shedding) of old bone, which is typically followed by remodeling, the growth of new bone. In healthy adults, cortical bone is constantly being resurfaced, such that the entire adult skeleton is overhauled every 10 years or so.

But that resurfacing process begins with resorption, and if resorption is slowed by bisphosphonates, the remodeling process is also affected. The result: The existing bone ages and gets brittle over time. “It’s kind of a double-edged sword. It’s extremely good to prevent bone loss, but the drugs will also slow this natural process, which allows turnover.”

The other unforeseen side effect to long-term bisphosphonate use involves crack-deflection—the resurfaced bone’s ability to stop a microscopic crack from propagating, which can lead to a break. New layers of bone can act as a “firewall” of sorts, stopping a crack from spreading, but mineralized, older bone loses that function."

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@daisy17 After posting the above comment, I forgot to add the attached article that I mentioned. Here it is: https://www.futurity.org/bisphosphonates-atypical-femoral-fracture-1509822-2/

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Profile picture for daisy17 @daisy17

@cat1203 This is very disturbing. It makes me angry and feel like women are guinea pigs to the drug industry.

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@daisy17 Well it does make one think a little harder before taking osteo drugs and consider your specific risk of fracture and whether the benefits outweighs the risks. At least they updated the label. But sometimes it seems like bisphosphonates are prescribed like candy. I wouldn't take it if I just had osteopenia, myself. It does seem crazy that the drug you're taking to prevent a fracture can itself cause a fracture. And I think you're right--if this were a condition that affected primarily men, I think we'd see more research, less risky drugs, etc.

REPLY
Profile picture for daisy17 @daisy17

@gracierose This website lists joint pain as a side effect of Fosamax: https://www.goodrx.com/alendronate/common-side-effects

My Dr prescribed Fosamax and I declined because I've read that, although it reduces bone breakdown it also reduces formation of new bone. Studies show bisphosphonates offer minimal benefits at fracture prevention, and isn't that the point of taking any bone drugs?

Here are a couple studies on the "absolute risk" vs benefit of bisphosphonates: https://www.amjmed.com/article/S0002-9343(24)00101-3/fulltext
From that study: "When the baseline risk is low, use of relative risk alone is likely misleading. According to the review conducted by the ACP, the relative risk reduction of hip fractures with bisphosphonate treatment for at least 3 years is 36%; however, the absolute risk reduction is only 0.6%. Framed as number needed to treat, 167 patients need to be treated for 3 years to prevent one hip fracture."
"The benefits of treatment in older or less functional adults are less certain, as clinical trials mostly excluded adults over age 80 and residents of long-term care facilities; limited data in both subgroups does not support a fracture risk reduction. In addition, the long-term benefits of fracture risk reduction must be considered in the context of functionality and life expectancy. The time to benefit for bisphosphonates is estimated to be 1-2 years for important clinical outcomes like hip fracture and vertebral fractures."

Another study:
https://www.consumerreports.org/cro/2012/04/popular-osteoporosis-drugs-come-with-mounting-concerns/index.htm
"Bottom line. Bisphosphonates offer only modest benefits in building bone and preventing fractures, and that should be considered along with the risks.”

I recently posted a discussion on the benefits of taking high doses of Vitamin K for osteoporosis. You can look for it under this support group.

Jump to this post

@daisy17
Thank you! I wonder why we aren’t just told to greatly increase calcium intake and just forget the whole alendronate/meds thing!!! I am definitely feeling joint pain and upset stomach, as well as EXTREME anxiety in my third month of taking this once a week dose of alendronate. But with having had breast cancer with chemo and mastectomy with implants 10 years ago, I get kind of crazy and don’t know where to look for answers and relief…

REPLY
Profile picture for gracierose @gracierose

I started alendronate once a week about 3 months ago and seem to be more uncomfortable and more joint pain than before. Is this normal? And if there are warnings about fractures while on it, is it really worth it to take this drug? I guess I really don’t understand why not just increase calcium intake to try to improve bone density.

Jump to this post

@gracierose
Remember to take Vitamin K if you take Calcium.
This vitamin helps to ensure that the Calcium is directed to the bones, and does not end up in the bloodstream. Just look it up. There is lots of information available.

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