Prolia Problems with Bone Fractures Comparable To Those Linked To Fosamax, Study Finds

Amid continuing concerns about the link between Prolia and bone fractures, the findings of a new study suggests that the risk of problems with Prolia are similar to those seen in prior years with the other osteoporosis drug Fosamax, where users report suffering hip fractures and other bone fractures with little or no trauma.

In a study published this month in the medical journal JAMA Network Open, researchers from Denmark compared the three-year incidence of hip fractures and other types of fractures between Prolia and Fosamax, finding that the rate of problems was comparable between the two bone drugs.

Prolia (denosumab) was introduced by Amgen in 2010, and was the first drug approved by the FDA for the treatment of postmenopausal osteoporosis.

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Side effects of Prolia may increase the risk of hip fractures, femur fractures and other bone fracture problems.

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Fosamax (Alendronate) is an older osteoporosis drug introduced in 1995, which has been linked to an increased risk of atypical bone fractures, typically involving falls from standing height or less, resulting in the FDA requiring updated warnings about the risk of sudden bone fractures in 2010.

In 2013, the prominent consumer watchdog group Public Citizen raised concerns that the side effects of Prolia may increase the risk of low-trauma fractures, indicating that the drug appears to interfere with bone metabolism and the body’s immune system, resulting in breaks that may occur in situations that would not typically result in such an injury.

Although Amgen issued warnings about the Prolia bone fracture problems in Canada as early as 2012, concerns have been raised that insufficient warnings are still being provided in the United States.

Earlier this month, Public Citizen filed a petition with the FDA calling for the agency to require a “black box” Prolia fracture warning, which would be the strongest warning the drug maker could be required to add to the label.

In this new report, researchers conducted a population-based cohort-study using data on more than 92,000 individuals 50 years or older in Denmark from May 2010 to December 2017.

According to the findings, the three-year cumulative incidence of hip fracture with Prolia was 3.7%, compared to 3.1% with Fosamax, an older osteoporosis drug. The study also found that the three-year cumulative incidence of any fracture was 9% for both.

“In this nationwide cohort study based on routinely collected data in Denmark, treatment with denosumab and alendronate were associated with similar risks of hip and any fracture over a 3-year period,” the researchers concluded. “Sex, age, and fracture history were not associated with patients’ risk.”

Amgen has acknowledged that there users face an increased risk of fractures after stopping the drug, but company has indicated that it believes the benefits to patients outweigh the risks. However, Public Citizen’s petition says the science is pointing to those risks being bigger than first believed.

As more consumer learns that problems suffered in recent years may have been avoided with stronger warnings, it appears likely that Amgen may face Prolia bone fracture lawsuits, raising allegations similar to those presented in several thousands Fosamax lawsuits in prior years.

22 Comments

  • MarianneJune 19, 2022 at 3:54 pm

    I have osteoporosis and my rheumatologist suggested I start on Prolia injections. I was tolerating the injections well and then 1 month after my last injection I experienced the most vicious groin and upper thigh pain. At first the doctor thought it was a hip injury. I went to the hospital and was given a nuclear injection and then X-ray and it showed that I had a femur fracture. I then acci[Show More]I have osteoporosis and my rheumatologist suggested I start on Prolia injections. I was tolerating the injections well and then 1 month after my last injection I experienced the most vicious groin and upper thigh pain. At first the doctor thought it was a hip injury. I went to the hospital and was given a nuclear injection and then X-ray and it showed that I had a femur fracture. I then accidentally fell off my bed and my L2 disc burst into pieces. I literally spent weeks in bed crying as nothing they gave me could relieve the intense pain.

  • Retha WNovember 16, 2021 at 4:33 am

    I have had 2 injection of Prolia.. I was fine with the first but 6 months later October 20th. I got the second one. I have so many side effects..My right hip groin hurts so bad when I walk I have to use a walker. Also I have alot of pain in my sciatic and lower back pain..I didn't have any of this before that shot..I see my primary care doctor every 6 months and he couldn't believe I was having [Show More]I have had 2 injection of Prolia.. I was fine with the first but 6 months later October 20th. I got the second one. I have so many side effects..My right hip groin hurts so bad when I walk I have to use a walker. Also I have alot of pain in my sciatic and lower back pain..I didn't have any of this before that shot..I see my primary care doctor every 6 months and he couldn't believe I was having to use a walker and take pain medicine..The time before when I went to see him he ask if I was in any pain. I said no I haven't taken any pain medicine in a long time.. My pain was so bad I had to go see him early instead of December 22nd. He told me to take Calcium and Vitamin D..I take Calcium and Vitamin D. He wants to see me in 6 weeks again.. Achy pain in joints..Back of neck and head..This is ruined my life..I am 80 year and was so active..I can't go shopping with my daughter for Christmas presents for our Family..I am at home resting and taking pain medicine..

  • BonnieNovember 13, 2021 at 7:11 pm

    My Sister was encouraged to take Prolia by her doctor. Now she has lost all her teeth and her jaw bone is also affected, so she is now having problems with her dentures staying in place. Now she is in debt thousands of dollars. There needs to be a class action lawsuit to help the victims of Prolia.

  • PeggyOctober 28, 2021 at 12:05 pm

    My 4th prolia shot is coming up in December. I will not get another one of these shots!! I noticed right after my first shot, that my joints, muscle pain was worse than ever, but chalked it up to my osteoarthritis, or stress with my job. It subsided, but came back before I was ready for for 2nd shot. I spoke to my doc about it, and he asked me to try it again, as this shot is really suppose to[Show More]My 4th prolia shot is coming up in December. I will not get another one of these shots!! I noticed right after my first shot, that my joints, muscle pain was worse than ever, but chalked it up to my osteoarthritis, or stress with my job. It subsided, but came back before I was ready for for 2nd shot. I spoke to my doc about it, and he asked me to try it again, as this shot is really suppose to help a lot with strengthening my bones. I did, and got a long somewhat ok for the 6 months after the 2nd one, so decided to take my last one in June, and in July, started having terrible right thigh issues, to the point of where I couldn't walk on some days. Found it extremely hard to go up and down stairs, as I've always been an active person. Then for no apparent reason, cracked a rib which took several weeks to heal, then started having jaw and ear pain, and bent over to wash my hair, and couldn't get up...my whole body was frozen. It took about a week before I was able to get around again. My concentration is not good, and I just retired in July, and had all these things I wanted to do, but now can't wait to get home to my heating pad...This injection is horrible, and I pray for all others who are having the same issues...

  • JaniceJuly 20, 2021 at 3:23 pm

    I received a prolio shot in 2020,I want off of it,because I started having pain in my right shoulder and alway down to my swollen hand,the pain kept me up at night and has gotten worst.I can’t stretch, because I get leg cramps.I had to get an x-ray because I’m having pain around my ribs ,still waiting for results. I have a weak immune system, I should never have been put on prolio

  • MaryannMay 27, 2021 at 6:19 pm

    I had two injections of Prolia my first one was in October of 2019. The doctor I went to needed prior authorization to administer my injection. That was set up through my insurance and approved. When I got to the office they said they had no record of the authorization.I spent two hours making sure that the authorization was faxed over to them and I received my first injection. My next injection w[Show More]I had two injections of Prolia my first one was in October of 2019. The doctor I went to needed prior authorization to administer my injection. That was set up through my insurance and approved. When I got to the office they said they had no record of the authorization.I spent two hours making sure that the authorization was faxed over to them and I received my first injection. My next injection was due in April 2020. I had trouble getting the Prolia from the specialty pharmacy to the doctors office due to administrative snafus. I finally received my second injection at the end of June 2020. I told the nurse who administered the Prolia that I leave for Florida in December and asked her what should I do being that the Prolia should be given every 6 months. She told me that I could get the drug injected in March 2021. I never received any warning of what could happen if the Prolia injection was delayed. On February 12th 2021 I suffered 3 compression fractures of my upper lumbar region of my back. I returned home from Florida I tried to contact my doctor and found that she had quit her practice and moved to California. I was never given a notification and my mail is monitored by three sources. I consulted with a University Hospital in Chicago and was told that the fractures were probably due to the disruption of Prolia injections. I was also told that I could no longer take Prolia because of the fractures. I started to look at side effects of Prolia; the more I learn I become more and more fearful of what my health problems will be in the future. I am currently in a brace and receiving physical therapy after I get out of the brace. It is difficult for me to get out of bed and care for my family and my home. I am the mother of a 29-year-old handicapped young man. Caring for him in the condition my back is in has become very difficult. I fear I will not be able to care for him if my health continues to deteriorate because of the Prolia injection‘s. I am very interested in joining any legal actions taken against the makers of Prolia.

  • SusanApril 9, 2021 at 12:33 pm

    After my first and only injection of prolia a year ago I started hadving problems. Aside from worsened joint issues, I have been diagnosed as having prolia-related osteonecrosis of the jaw. My teeth have visibly and seriously shifted and bone is coming through at the gum line. My bite is affected and I am going to lose two more healthy teeth that are visible and make me extremely self-conscious.[Show More]After my first and only injection of prolia a year ago I started hadving problems. Aside from worsened joint issues, I have been diagnosed as having prolia-related osteonecrosis of the jaw. My teeth have visibly and seriously shifted and bone is coming through at the gum line. My bite is affected and I am going to lose two more healthy teeth that are visible and make me extremely self-conscious. I am a person who smiles a lot and I find I want to cover my mouth or turn away. I am told I probably won't be able to have implants. There are other issues as well. I am anxious to have this drug exposed for its potential devastating effects on people. Prolia should be taken off the market and people need to know about it. I am most interested in joining a class action suit against Amgen. They have not heeded all the many severe reactions to prolia and now they are pumping its advancement through advertisement.

  • AnitaFebruary 24, 2021 at 5:04 pm

    I was put on Prolia for osteoporosis. I had 9 injections. I decided to try going off of it because of skin problems and easy bruising and bleeding. Shortly after I had compression fractures in spine. I had 4 kyphoplastys. I’m in constant pain in lower back. Meanwhile we moved to Minnesota. The bone people here were aghast that I was on Prolia. They took me off immediately and now I’m on Reclast[Show More]I was put on Prolia for osteoporosis. I had 9 injections. I decided to try going off of it because of skin problems and easy bruising and bleeding. Shortly after I had compression fractures in spine. I had 4 kyphoplastys. I’m in constant pain in lower back. Meanwhile we moved to Minnesota. The bone people here were aghast that I was on Prolia. They took me off immediately and now I’m on Reclast. Still having back pain, but bleeding and easy bruising is almost gone. PT is helping some but I will never without pain when walking.

  • CarolFebruary 9, 2021 at 4:18 pm

    I am currently taking prolia Asit will be 4 years. Currently I have really no problems except for stiffness in my hip and soreness . I would like to quit this but I don't know how bad that would be so now I am afraid to stop.

  • KathyJanuary 15, 2021 at 6:14 am

    I have Osteonecrosis of the jaw from taking Prolia injections for 5 years. I had to have an extraction and the site would not heal. Bone began to come through my gums and an oral surgeon had to remove it. My teeth have been decaying quickly, have become brittle and break off at the gum line. I could not have implants or do anything that would involve the bone. I have a gaping part of my jaw missin[Show More]I have Osteonecrosis of the jaw from taking Prolia injections for 5 years. I had to have an extraction and the site would not heal. Bone began to come through my gums and an oral surgeon had to remove it. My teeth have been decaying quickly, have become brittle and break off at the gum line. I could not have implants or do anything that would involve the bone. I have a gaping part of my jaw missing and found out today that I have to have one of the broken teeth extracted next week. We have no idea how the rest of my jawbone will be affected. I have spent thousands of dollars so far, Medicare will not cover this and I am almost 69 years old. Amgen needs to step up and help us! If there is a class action suit or if any attorney wants to look into this further, please count me on the top of the list.

  • ElizabethDecember 15, 2020 at 7:59 pm

    I was giveing prolia injection doctor never gave me any information about side effects , more did he even give me the name of the medication I was injected with, have had so many side affects since inection the list is to long to even mention. I only got the one injection in March of 2020 and every thing in my body is going wrong! Reported it to the F D A and there manufacture. I blame the doctor [Show More]I was giveing prolia injection doctor never gave me any information about side effects , more did he even give me the name of the medication I was injected with, have had so many side affects since inection the list is to long to even mention. I only got the one injection in March of 2020 and every thing in my body is going wrong! Reported it to the F D A and there manufacture. I blame the doctor for not telling me what the name of the drug was before I was giving it and not giving me any information about it at all. I'm 76years old and I live with constant pain and fear of what else this drug will do to me.

  • TambraSeptember 26, 2020 at 10:16 pm

    I had a laundry list of chronic conditions that my rheumatologist was familiar with. After two shots I told my rheumatologist I wanted to stop the injections. He kept telling me it was gong to be worse if I didn't take Prolia. I kept refusing and he continued to push the drug on me. I told him of the side effects directly related to Prolia with printed information and still he refused to listen. I[Show More]I had a laundry list of chronic conditions that my rheumatologist was familiar with. After two shots I told my rheumatologist I wanted to stop the injections. He kept telling me it was gong to be worse if I didn't take Prolia. I kept refusing and he continued to push the drug on me. I told him of the side effects directly related to Prolia with printed information and still he refused to listen. I don't just have asthma now, I also have asthma related COPD. The asthma got worse as well as the added COPD symptoms and I've never smoked in my life. I also have eczema because of it. I've never had eczema before the Prolia. I have TMJ and it's worse. Recently, I've had five months of iron infusions for anemia which has never been this bad before. I started Prolia in early 2016 and finally got off of it in September 2017. The medical issues continue and I'm furious. We need justice and compensation. Even with my chronic health conditions Prolia has stolen more of the quality of life I had before it. Someone needs to take the side effects of this drug seriously and come up with a solution to restore the health taken away from the patients forced by doctors who care about the drug companies than their patients.

  • GraceSeptember 22, 2020 at 10:10 am

    I have been given Prolia injections for quite some time. I used to have Fosamax, then a Aclasta infusion, my doctor said that the Prolia was much better than the Aclasta, because it was just one injection, compared with the inconvenience of 3/4 of an hour of sitting through the infusion. I was informed my last bone density was 4 years ago, so my doctor has sent me for a recent one, at another hos[Show More]I have been given Prolia injections for quite some time. I used to have Fosamax, then a Aclasta infusion, my doctor said that the Prolia was much better than the Aclasta, because it was just one injection, compared with the inconvenience of 3/4 of an hour of sitting through the infusion. I was informed my last bone density was 4 years ago, so my doctor has sent me for a recent one, at another hospital, as it is a newer machine & she has had blood tests taken & asked me why I changed to prolia, I said because of what the other doctor had said. I have terrible pain in my back, legs, hands wrist & individual fingers. Unable to do many crafts/sewing & general home duties. So sorry I went down this path.

  • KimberlySeptember 2, 2020 at 11:05 pm

    I was receiving Prolia injections for 5 years for the treatment of osteopenia and osteoporosis. It was my understanding that I could be on it for 5 years. I also take a calcium supplement and D3. 12 months after my last Prolia injection I developed back pain and had difficulty walking. My MRI showed multiple vertebrae fractures. I had no injury and I could not understand how I went from a very act[Show More]I was receiving Prolia injections for 5 years for the treatment of osteopenia and osteoporosis. It was my understanding that I could be on it for 5 years. I also take a calcium supplement and D3. 12 months after my last Prolia injection I developed back pain and had difficulty walking. My MRI showed multiple vertebrae fractures. I had no injury and I could not understand how I went from a very active person to someone with constant back pain and difficulty walking. I soon found out after reading numerous articles about discontinuing Prolia. I wish my doctors and myself would have done more research.

  • MaureenJune 3, 2020 at 10:19 pm

    I was prescribed to get the Prolia shot done by an injection practice. I was not told any negative effects, I was handed a disclosure sheet and advised to read it before I had the shot , which I did. It was very strange to read that a product that was developed to stop bone loss and fractures could, in fact , cause more of them. I had 1 shot and then 4 months later I started having ALL of my te[Show More]I was prescribed to get the Prolia shot done by an injection practice. I was not told any negative effects, I was handed a disclosure sheet and advised to read it before I had the shot , which I did. It was very strange to read that a product that was developed to stop bone loss and fractures could, in fact , cause more of them. I had 1 shot and then 4 months later I started having ALL of my teeth ache at the same time. Then I started to lose my teeth one .at a time. It was terrible! I even swallowed the top half of one of them. Most of them broke off the top and the roots are still buried in my jaw. I had no pain and no problems with the teeth before hand. As of this time, I have one very loose tooth and I have at least 6 set of roots buried under the gums that cause very little pain. I went to an oral surgeon for a price to fix the problems cost will be at least 5 thousand that I don't have. This problem was NOT listed on disclosure sheet.

  • SuzanneFebruary 14, 2020 at 8:48 pm

    I was told to take this horrible drug after taking Fosamax for 3 months which did not agree with me. I am so glad I didn't take it reading these awful stories. These are people's lives and it's not good enough that these drugs are pushed on us by professionals.

  • PaulineJanuary 31, 2020 at 9:22 pm

    I have been on prolia for over 5 years . Since starting it I have had two vertebrae fractured in September 2017, two January 2019 and 6 March 2019. I was late taking one shot in October 2018 and took it in April 2019. No one ever told me if I was late taking a shot it increased my risk for fractures. My back is in constant pain and I am still in an osteoporosis state. My Endocrinolgist is changi[Show More]I have been on prolia for over 5 years . Since starting it I have had two vertebrae fractured in September 2017, two January 2019 and 6 March 2019. I was late taking one shot in October 2018 and took it in April 2019. No one ever told me if I was late taking a shot it increased my risk for fractures. My back is in constant pain and I am still in an osteoporosis state. My Endocrinolgist is changing my therapy to a new drug in February.

  • NancyDecember 22, 2019 at 1:18 am

    My husband died as a result of this drug. He received his 1st and only injection in August 2018 passed away December 2018. This drug needs to be taken off the market and a class action lawsuit needs to be filed.

  • DavidOctober 13, 2019 at 12:30 am

    My mom stopped taking Prolia and six months later was debilitated by 4 spinal fractures one right after another. Now she has been told this similar situation is not uncommon by doctor???? Now I start looking into this more and find hundreds of similar situations on-line. This drug took her from kicking soccer balls with my son one year to being almost immobile. A class action needs to be started a[Show More]My mom stopped taking Prolia and six months later was debilitated by 4 spinal fractures one right after another. Now she has been told this similar situation is not uncommon by doctor???? Now I start looking into this more and find hundreds of similar situations on-line. This drug took her from kicking soccer balls with my son one year to being almost immobile. A class action needs to be started and sounds like it will. This is criminal what has occurred to so many.

  • KimberlyAugust 30, 2019 at 5:47 am

    In May I took a minor fall & had no damage not even a skinned knee; nothing. Two weeks later sever pain on my right rib cage sent me to xray. I have a fracture. Four months later it is not healing. Hard to breath, move & function. In the mean time I lost lower right pre-molar eating a soft mint. $2700 later the hole has been prepped for implant. While healing from oral surgery I lost the left side[Show More]In May I took a minor fall & had no damage not even a skinned knee; nothing. Two weeks later sever pain on my right rib cage sent me to xray. I have a fracture. Four months later it is not healing. Hard to breath, move & function. In the mean time I lost lower right pre-molar eating a soft mint. $2700 later the hole has been prepped for implant. While healing from oral surgery I lost the left side pre-molar. Otherwise my teeth are healthy. I’m sure the remarkable tooth loss is a function of Prolia side-effect. To restore my mouth it is costing upwards of $4800 per tooth. Needless to say I’m furious & think Prolia must be incentivizing doctors to prescribe it. It’s unconscionable to give this deleterious chemical to anyone. I feel like a lab rat.

  • patJuly 14, 2019 at 7:42 pm

    I took prolia injections for 1 1/2 years after hip fracture. Disastrous side effect, it caused my upper hard pallet and jawbone to disintegrate...spawned a tumor from the roof of my mouth to my left sinus cavity. Thank God the tumor was benign but now I have no teeth upper and the front two bottom, this was the most painful thing I have ever gone through. Does Amgen care that their product did thi[Show More]I took prolia injections for 1 1/2 years after hip fracture. Disastrous side effect, it caused my upper hard pallet and jawbone to disintegrate...spawned a tumor from the roof of my mouth to my left sinus cavity. Thank God the tumor was benign but now I have no teeth upper and the front two bottom, this was the most painful thing I have ever gone through. Does Amgen care that their product did this, and I am sure I am not alone.

  • Kathleen AJune 24, 2019 at 12:52 am

    I had osteopenia and fractured my hip in a fall. I had a Total hip replacement. 3 MDs encouraged me to take Prolia and I was reluctant but started it 9 months after the surgery. At 1 Year and 3 months post op February 2019,I starting have mid femur pain in operative leg. It was intermittent. In May I had a bone scan which suggest early loosening. I’m concerned about the Prolia, I have had 2 inject[Show More]I had osteopenia and fractured my hip in a fall. I had a Total hip replacement. 3 MDs encouraged me to take Prolia and I was reluctant but started it 9 months after the surgery. At 1 Year and 3 months post op February 2019,I starting have mid femur pain in operative leg. It was intermittent. In May I had a bone scan which suggest early loosening. I’m concerned about the Prolia, I have had 2 injections so far. I can’t find anything in the literature.

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