This past June 1st, the FDA approved Prolia ™ (denosumab), a brand new twice-yearly injectable osteoporosis drug by Amgen.
The first drug of its kind, Prolia was designed to treat and prevent postmenopausal osteoporosis for patients considered to be at high risk of fractures. It's also marketed as an alternative treatment for those who have failed or are intolerant to other osteoporosis drugs.
Is this a time to celebrate, or is Prolia destined to end up in the osteoporosis “Hall of Shame”, along with the rest of Big Pharma’s Superstar osteoporosis drugs? I’ll let you decide, but first, let’s unravel the mysterious and tightly-woven cocoon wrapped around this novel drug.
An Old and Flawed Concept Disguised as Sci-Fi Technology
As if straight out of a sci-fi movie, the Space Agency NASA was involved in several studies related to Prolia. Here’s the scoop: in 2001, Ted Bateman, Ph.D. from Clemson University in South Carolina and Paul Kostenuik, a researcher for Amgen, teamed up to “…use the microgravity environment for evaluation of new pharmaceutical candidates (denosumab) in small mammals. Results may expedite the review of new pharmaceuticals.”1
They conducted studies on 24 female mice that spent 12 days on the International Space Station shuttle flight STS-108. Study findings confirmed that Prolia did prevent increased bone loss and maintained bone mineralization. So there you have it. The medical establishment is more than willing to send mice to space – but would they consider a natural, safe, and easy treatment? Out of the question!
On the surface, Prolia seems to be a breakthrough and fairly innocuous drug. But is it? As the first fully human monoclonal (laboratory-made) antibody and RANK Ligand inhibitor to be approved as a drug, it certainly sounds very complicated. But it really isn’t. Bear with me… I’ll explain.
Antibodies are proteins produced to neutralize “invaders”, such as bacteria and viruses. RANK Ligand (RANKL for short) is a protein that activates osteoclasts and is involved in immune-response regulation.2 As I explain in the Osteoporosis Reversal Program, osteoclasts are bone cells that remove old bone by a process called resorption. They make space so that new bone is deposited by osteoblasts, thus replacing old bone. These two processes are known as bone remodeling, the natural way by which bones renew themselves and stay strong, healthy, and more resistant to fracture.
Prolia: Same as Bisphosphonates… Only Different
Now back to Prolia. The natural inhibitor of RANKL is osteoprotegerin, a tumor necrosis factor (TNF) cytokine that binds to RANKL, preventing interaction with its receptor-activator RANK on the surface of osteoclasts.3 Cytokines are chemical messengers that help regulate the nature and intensity of an immune response. Remember this for later, because it all ties in together.
So, in plain English, Prolia mimics osteoprotegerin by blocking the effects of RANKL and de-activating osteoclasts. Say “hello” to stalled bone resorption and “good-bye” to new bone deposition. But wait a minute, doesn’t this sound eerily familiar? It should, because bisphosphonates achieve the same end result as Prolia, only through a different biochemical pathway.
At the end of the day, both drugs alter normal bone metabolism, not without potential long-term nefarious consequences. For example, sudden femoral fractures are linked to long-term bisphosphonate therapy, which can be attributed to the lack of bone remodeling. Add to this formula a dose of immune system tampering, and you’ve got yourself a fully assembled health Molotov cocktail.
Studies and Stats
Amgen’s own Press Release states that “Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip and non-vertebral fractures measured at three years.”4 It backs up this statement with a study by Cummings et al. published by the New England Journal of Medicine in 2009, titled “Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis”.
And the same Press Release boasts their pivotal three year Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months or “FREEDOM” study (no, this is not a bad joke) with these results:
– 4.8 percent absolute risk reduction of vertebral fractures - 0.3 percent absolute risk reduction of hip fractures - 1.5 percent absolute risk reduction of non-vertebral fractures - 8.8 percent bone density increase at the lumbar spine, 6.4 percent at the total hip, and 5.2 percent at the femoral neck.
So far, so good, especially for those who don’t mind being “guinea pigs” in exchange for short-term rewards. Because the biggest cause for concern with Prolia is its potential side-effects.
A Wolf in Sheep’s Clothing
Even though Prolia doesn't accumulate in the body and has no known esophageal side effects as is the case with bisphosphonates, it boasts a rather long list of undesirable – and sometimes dangerous – potential side effects. In its shadow, bisphosphonates almost seem to be the lesser of both evils, and that’s no small feat. You’ll soon know why.
The most common side effects of Prolia are back pain, arm and leg aches, elevated cholesterol, general musculoskeletal pain, bladder infection, and pancreatitis.5
And as disclosed on the Prolia website (https://www.prolia.com), it can cause serious side effects because it “is a medicine that may affect your immune system” (remember the cytokines?).
These are the main side effects listed by Amgen:
- Low calcium levels
- Serious skin, lower abdomen, bladder, or ear infections
- Dermatitis, rash, or eczema
- Inflammation of the inner lining of the heart (endocarditis) caused by an infection
- Severe jaw bone problems such as osteonecrosis of the jaw.
And for dessert, Amgen serves up a cautionary statement: that “it is not known if the use of Prolia over a long period of time may cause slow healing of broken bones or unusual fractures.”
So it looks as though…
The More Things Change, the More they Stay the Same
Like bisphosphonates, Prolia opens the door to a wide array of opportunistic health problems, many of which can (and trust me, will) get covered over with yet more drugs.
And let’s not forget that this drug interferes with the body’s natural immune system, which is the obvious reason for many of its most dreaded side-effects. In fact, roughly one year before its approval, FDA reviewers expressed concerns over Prolia’s activity against an important immune system modulator.6
But evidently, those concerns were shoved to the side and quickly forgotten. It seems as though the medical establishment considers drug side-effects – no matter how terrifying – an unfortunate “numbers game”. Applying its skewed logic, it accepts that there will always be some unlucky patients that will get stuck with irreversible damage, such as osteonecrosis or endocarditis – the latter potentially resulting in heart valve destruction or even a stroke.7 The unsuspecting victims are written off as inevitable casualties of war, losing their battle, but helping win the war against “disease”.
Don’t Get Fooled by Confusing Double-Speak
It almost seems as though well-meaning scientists focus so disproportionately on solving bone health issues using hi-tech tools, that they lose sight of the risk vs. reward ratio. That's why together at Save Our Bones, we expose the truth and dispel misconceptions, especially as they relate to brand new drugs.
Let’s face it: two injections a year may sound like an appealing solution to finally conquer osteoporosis. But the bad news is the potential high price to pay. So I urge you to consider your acceptable options and weigh the consequences of your decision. Also, please share this review with anyone you think may benefit from it.
And ALWAYS remember the good news: the Save Our Bones community is here for you and your bone health, with proven natural bone health strategies that work with your body… not against it.
References
1 Commercial Biomedical Testing Module: Effects of Osteoprotegerin on Bone Maintenance in Microgravity (CBTM). https://www.nasa.gov/mission_pages/station/science/experiments/CBTM.html].
2 Lacey DL, Timms E, Tan HL, Kelley MJ, Dunstan CR, Burgess T, Elliott R, Colombero A, Elliott G, Scully S, Hsu H, Sullivan J, Hawkins N, Davy E, Capparelli C, Eli A, Qian YX, Kaufman S, Sarosi I, Shalhoub V, Senaldi G, Guo J, Delaney J, Boyle WJ . Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell. 93:165–176. 1998.
3 Nakagawa N, Kinosaki M, Yamaguchi K, Shima N, Yasuda H, Yano K, Morinaga T, Higashio K. RANK is the essential signaling receptor for osteoclast differentiation factor in osteoclastogenesis. Biochemical and Biophysical Research Communications. 253:395–400. 1998.
4 https://wwwext.amgen.com/media/media_pr_detail.jsp?releaseID=1433162
5 https://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1104
6 https://www.medpagetoday.com/ProductAlert/Prescriptions/15486
7 https://www.nlm.nih.gov/medlineplus/ency/article/001098.htm
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Right on the prolia website it says if you stop the drug, you are more prone to spinal fractures – more so than before treatment! I am reading reports of spinal fracs after stopping prolia. I just finished 2 yrs of forteo with no gains in bone density. Very disappointing! Now I’m trying a RX supplement called FosteumPlus. Hope it helps. I don’t have faith in these osteo drugs at all and don’t feel I want to risk the side effects. I know my Dr. , who is suggesting Prolia now, won’t be happy with me.
Please do not go on Prolia. It tampers with your immune system and is very likely to cause an auto immune response that may stay with you for life. I strongly suggest you follow a healthy diet, the proper weight bearing exercises and forget about Prolia….I have suffered tremendously because of the one and only injection of this drug that plays with the natural bone building and disposing processes in order to recycle worn out bone back to your healthy bones….eventually causing serious fractures, among other problems…Good luck to you!
I am on Arimidex (Anastrazole) for prevention of recurrence of breast cancer. My osteoporosis has gotten worse since being on it for one and a half years. I’m 64 and my bone density is -37. My Dr wants me to go on Prolia and I am very concerned after reading this article but I am also concerned about my bones since I have to be on Arimidex for another 3 and a half years longer. I don’t know what to do since my bone density had really deteriorated in one year. Any advise is appreciated.
Hi Jane,
Arimidex and other estrogen-inhibiting drugs do have a negative effect on bones, so that’s actually even more reason to follow a pH-balanced, bone-smart diet. Such a diet can offer protection against bone loss caused by Arimidex – it’s a better option than yet more prescription drugs, which add to the toxic load.
Also, a pH-balanced diet aims to retain the necessary minerals in the body so as not to deplete bones, and in fact, some scientists believe that an alkaline pH not only helps retain important minerals, it also may stave off cancer from recurring. So it may have a double benefit.
But remember, this is your decision; I am not a doctor, and you and your oncologist need to discuss your options (including your knowledgeable decision to take or not take Prolia or other osteoporosis drugs). I wish you success moving forward!
I am taking arimidex for life. I have gone through 3 rounds of cancer, chemo, and radiation (ovarian cancer/breast cancer/reoccurring breast cancer). When I had breast cancer the first time, I was prescribed Prolia and took 4 injections over 2 years. After the first injection I experienced blurred vision and thought it must be the arimidex and stopped taking it. After I had a reoccurrence, I realized I had no choice, so started taking arimidex again. So far about 6 months I’ve had no problems. Two weeks ago, My oncologist recommended I go back through a series of Prolia injections. Within a week later, my vision got blurred and I’m really struggling. Is this be a side effect of Prolia? And if yes, will it go away if I don’t take any more dosages. I’m miserable and work in a job where I use the computer all day. Having blurred vision is very challenging. Thanks for any feedback.
PLEASE PLEASE Do not take these injections. I had my first injection10 months ago. I developed severe jaw pain a few weeks after the injection. I have never had any dental problems. My dentist, not being able to diagnose the problem , sent me to a specialist and he too could not find a problem. Only after receiving my second injection did I then realize that this was a reaction to the prolia. After this second injection I have had heart flutters (Which I have had to go to a Electrocardiologist heart doctor and wear a monitor for a week.} I also have been having jabbing back pains that come and go, and now I again have the extreme jaw pain that has this time included pain in my ear. Very difficult to eat. When I mentioned it to my doctor, she had to look up the side effects. Wish I would have done my homework earlier and knew how devastating this drug is. Wish doctors would do the same.
J Hall
At age 72, I am on Prolia after breast cancer treatments because of needing to use an aromatase inhibitor, and I also have osteopenia. I have no side effects. On the contrary, I feel ten years younger and no longer use a push cart when I am shopping. I have no increased pain, no problems with abdominal pains, and the slight rash I got on my ear responded to a calendula salve. I did increase my vitamin D3 intake and my calcium intake when I started it. I also have few other major conditions, and no history of autoimmune disease. For me it is a gift.
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My mother has Copd/emphysema. She also has osteoporosis and takes fosamax which she has been taking for years. She has been going to the mayo clinic trying to get a lung transplant. They told her they wanted to give her this shot to get her off the fosamax (which has nothing to do with the transplant.) Her bones are good and have been good the 7 seven years we have been going. She listened to them and agreed to it. That was 13 days ago. She came home ended up in the hospital 2 times the first week. Second time stayed there for 3 days and the doctors released her to hospice. Now their preparing me for her death. This shot completely shut down her body. The week before that shot she was eating, walking, shopping, on oxygen and she was struggling but with 24 hours of that shot she was down and hasnt been back up since. Do not agree to this shot. I really am researhing and trying to figure out if theres a way to reverse the damage it caused to her already fragile body. Im seeing alot of cannabis answers but im not sure hospice will agree to that. I need help. These doctors should not be playing roulette with peoples lives its not fair and definitely should have made my mom more aware to these side affects before giving it to her
She took Prolia?? Thank you and I hope your mom gets better
Hi Shannon, I agree with you, the doctors should not be playing roulette with our lives! I started taking Prolia in 2012 and was not told about all the horrible side effects! It has changed my life for the worst! Was originally for bone cancer patients! I have had horrible side effects and am still having them, will never take it again and I hope your Mom gets better soon!
Have had 2 injections. Been watching my monoclonal gammopathy for 10 years with very little change. All of a sudden my disease is now progressing into multiple myeloma. A big rise in my labs since my last injection in May. It has made a slight difference in my bone density but is it leading me to bone cancer? I have refused any more treatments and will start weight training and continue calcium supplements. I’m curious to see if any one else has this problem or if they know someone that does? Thank you
Debbie, I had all the horrible side effects of Prolia! It has been the worst drug I have ever taken. You are wise to never take it again, and I will never take it again. i have not experienced what you describe, but as I said it was a horrible drug for me. Hope you do well without Prolia.
hi I’m 52 & today after bone density scan found out I have osteo arthritis in my spine.doctor gave me script for prolia
I am fit I have started yoga don’t eat animals or drink cows milk
all my bloods are great.
any alternatives that anyone one can recommend to build up my bones please
I really don’t want to use this drug 🙁
Hi Janine, I am on Calcium with vitamin D, and some exercise with weights. I took Prolia trusted my oncologist, didn’t look up all of the side effects. Prolia has been horrible for me, personally, I will never take it again. My body and energy level has gone way down. Still suffering from the side effects and took my last shot in 2015. The drug was originally for bone cancer patients. Hope this helps you and good luck! Tell everyone no Prolia!!
Don’t start Prolia. Been receiving shots for 9 years. I have been having problems with my immune system and my research leads me to believe blame Prolia. I am starting an exit plan. Should mention that my immune system problem also led to postponement if my November shot. In Jan I performed a simple lift off on object I lift every day. That one move fractured three thoracic vertebrae and I will need surgery. As soon as I have recovered from the surgery I am going to exercise, eat the right foods etc but no more Prolia. I will take my chances. Forgot to mention that the compromised immunity led to two Shingles outbreaks. The first one almost cost the sight in.one eye, kept me housebound for 6 weeks with severe pain and an additional three months of nerve pain.
Hi, It nice to inform you all that I have done Chemo and Radiation 2 times for my Breasts. My battle with Breast cancer started 5 years ago, after so many Chemo, Radiation and other natural therapy treatment that i took just to cure my Breast cancer, it all didn’t work for my condition. I have been treating this disease for the past 5 years, but today i am here telling the world about my final victory over Breast cancer with the help of Rick Simpson Hemp Oil or cannabis Oil that I bought from Dr. Rick at:Ri*****************@*****ok.com, This is a breakthrough in my family with so much Joy in our life today, i do really appreciate all the help and contribution from every member of my family for all they did for me and much love to my caring and loving husband. My love, you gave me the strengthen. Let Stop Breast Cancer, Go for your test and save your life, but if you have any cancerous diseases, there is no need to waster money on Chemo or Radiation, go get your Rick Simpson medication from Dr. Kelvin at:Ri*****************@*****ok.com, this is a medication that should be legalize worldwide, for those who wish to purchase the medication, just contact Dr. Rick on:Ri*****************@*****ok.comfor purchase of medication.
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After months of trying the various oral medications for bone loss, my Doctor has suggested Prolia. I still have a rawness in my throat and esophageal side effects.
After reading all of your comments, I feel I will decide Prolia is not for me. I will continue the calcium and vitamin D.
Just wondering if anyone has researched the benefits of the K2D3 combo which is D3 1000IU & K2 120mcg in organic coconut oil, It is supposed to ‘assist the body in the absorption and utilization of calcium and the development and maintenance of bones and teeth’.
I welcome your comments, experiences, and knowledge.
Thanking you all, in advance.
Regards,
Trish
I really don’t know what to say about Prolia, as I’ve been receiving it for a while now but it doesn’t seem to be doing much. My last bone density test showed I am not losing more bone – but I am also not gaining any either. My doctor wants me to stay on it but the expense might not be worth it if it’s really not doing anything. I think as we get to a certain age (I am mid-sixties), we bottom out, i.e., we don’t lose more but don’t gain any either no matter what we do. Nature at work, so to speak. I take plenty of calcium and Vitamin D too (and have for decades), but things have stayed relatively the same bone mass wise since I went through menopause, reaching that point at age 53. That was 12 years ago! I’ve tried bisphosphonates but they too did little over the course of time. Have been taking the Prolia injection for awhile (about 5 injections now) and again, nothing to write home about. So, I really don’t know whether to continue Prolia if it’s not showing results. Seems kind of pointless in a way. have had no reactions to the drug so that’s good, but still, if it’s not showing results…
The info you have provided very useful. Good analysis.Great Job keep it up.
Thanks for sharing.
This drug has changed my mom’s life. She could not remember to take her other meds and they had awful side effects. Prolia is simple with two simple shots a year and the results on her scans show it is working. She has no side effects and she feels great!
Please help me make a decision. I have been advised by my doctor to take Prolia. I am very hesitant because of the side effects. I have severe osteoporosis. I don’t want a broken bone, but I don’t want what this drug offers, either.
Hi Dale, I too have been prescribed Prolia injection for severe osteoporosis and am having second thoughts. I already have Osteo arthritis and weak jaw bone and the thought of having Prolia really scares me but this is something everyone has to make up their own mind. Some of my teeth are already loose and a dead jaw bone due to Prolia if i have an extraction whilst on Prolia is scary. I am prepared to work at taking vitamins, having natural foods high in calcium (cannot take calcium tabs due to kidney stones) weight bearing exercise and natural protein as I have done a lot of research. I will go back in 6 months and have another bone density scan. I wonder how you went with your decision whether to have it or not. I do hope however if you went ahead that everything went well for you.
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I am over 83 years old with engineering and law degrees. I am trying to decide whether I should take Prolia or Forteo to help my soft bones. I have had four bags of blood transfusion that saved my life from immune deficient anemia that depleted my red blood cells. I returned to normal after treatment. Later I had a bad fall from my front porch and stairs that broke six ribs and gave compression fractures to two vertebrae. A surgeon fixed the broken bones. In American you have free speech except for slander and libel. The FDA wants you to report bad side effects on FDA Form 3500B (use this search term) that may be added to the list published with each medication.
I am still debating what to do abut my osteoporosis at age 70.
I am even considering bioidentical hormones.
My doctor is fabulous. He feels very strongly about my need for prolia. I am terrified of it. Does anyone feel it is worth taking
This is in reply to Robert A Felsman.
My 85 year old mother began having multiple fractures and extremely soft bones about 12 years ago. Every small accident resulted in fractures.
Her Orthopedist got her involved with a Forteo trial and her bone density increased by 15%. She had one further fracture due to a a very hard fall in a parking lot, but none of the other small tumbles she has had resulted in fractures. I was so relieved when she finally got this drug. She had broken at least 10 bones and spent months recovering. All that trauma to her body was exhausting for her.
I would seriously consider the Forteo. I think it saved her from becoming a complete invalid.
I hope this is helpful and good luck to you!
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