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Prolia 保骼麗 (Denosumab)
● Prolia 藥物副作用可能很嚴重 !
● 要小心使用 !
Denosumab is a fully human monoclonal antibody for the treatment of osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma, and giant cell tumor of bone. It was developed by the biotechnology company Amgen.
Denosumab is designed to inhibit RANKL (RANK ligand), a protein that acts as the primary signal for bone removal. In many bone loss conditions, RANKL overwhelms the body's natural defenses against bone destruction.
In June 2010, denosumab was approved by the U.S. Food and Drug Administration (FDA) for use in postmenopausal women with risk of osteoporosis under the trade name Prolia, and in November 2010, as Xgeva, for the prevention of skeleton-related events in patients with bone metastases from solid tumors. Denosumab is the first RANKL inhibitor to be approved by the FDA. In the summer of 2011 clinical trials were investigating denosumab in giant cell tumors, multiple myeloma with bone metastases, and hypercalcemia of malignancy, and further investigating its dosing and safety.
Prolia (Denosumab): My Review
By Vivian Goldschmidt, MA
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 Save Our Bones 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 Bisphophonates… 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 osteoblasts.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 (http://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.
1 Commercial Biomedical Testing Module: Effects of Osteoprotegerin on Bone Maintenance in Microgravity (CBTM). http://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.
July 18, 2010, 9:01 am
The goal of drugs companies is to make money not to cure people, its that simple. We will see more drugs in the market in the future because people buy them. For me the best alternative is the natural way, like many years ago where all these drugs didn’t exist. Now that we have them we see thar they make moredamage than good.
July 1, 2011, 2:58 pm
On the advice of her Dr. my 91 year old mother took the Prolia injection. Two months later she was in the hospital. She was in perfect health until taking the injection. She had a bleeding ulcer, blader infection, fluid on the heart and irregular heart beat. She spent a week and half at the hospital. They say report in serious side effects but they do nothing about them. When you have the side effects it is too late. Do not take the shot
July 16, 2010, 7:50 pm
Vivian: I have felt so much better since I have been off Fosomax and then Boniva. It is a pleasure to be able to raise my arms and do things I couldn’t do before because of pain.
I appreciate your study and comments and the latest with this new drug and I assure you, it will not be part of my diet. Thank you very much.
July 16, 2010, 1:00 pm
Interesting. Current issue of WORST PILLS, BEST PILLS NEWS had an article on bisphosphonates and NSAIDs. Says that there is evidence that people who ingest both have an increased risk of gastrointestinal ulcers. It also says that there is an increased risk when taken separately. The more pills we take, the sicker we get!
July 16, 2010, 8:45 am
Since 2005 my bone density numbers continued to go down. I had been taking Evista for a long time. Can’t remember when I started. I stopped taking Evista over a year ago. I exercise 6-7 hours per week. In January of 2010, my bone density numbers went up slightly. I was elated since the exercise started only a few months before that. My Dr. wanted me to continue the drug. I refused. He said that if I took the bone density test again on the same day, it my be different numbers. What does that tell you? He also mentioned that the drug prevents breast cancer. Well, how can one drug be curer of two conditions ???? No thank you. I will continue my current program of exercise and diet. Thank you Vivian for all your information.
Mary Ann Unger
July 15, 2010, 6:44 pm
Thanks for the heads-up on Prolia. As someone with low immune levels, I definitely will steer clear of something that might further compromise my immune system. I’m fed up with doctors who prescribe without looking at the med history of their patients. Your information cuts through the pharmajargon.
July 15, 2010, 3:42 pm
I am a NP in a large primary care office in ND and also an Osteoporosis pattient since I was 29. I was involved in the clinical trials for Denosomab, as both an investigator and a patient. I have read your emails for the past few years and agreed with you most of the time, but I have to tell you that I feel you did not do your homework on Denosomab/Prolia.
I was also involved with clinical trials of most of the major oral BP’s, and I can attest first-hand that Denosomab is an excellent alternative that is both safer and more effective than any other treatment options currently on the market.
In your review you wrote that Prolia’s most common side-effects were: back pain, arm and leg aches, elevated cholesterol, general musculoskeletal pain, bladder infection, and pancreatitis.5
But if you check their package insert data from their pivotal clinical trial, you will find that all of the above were equally balanced in the placebo group (eg 1307 patients had back pain on Prolia, and 1301 had back pain on placebo). To me and most clinicians, that means there is no back pain related to Prolia. In fact there were no statistically significant side-effects found between Prolia and the placebo group in their trial which included 7,808 woman across the globe.
You also mentioned opportunistic infections, but the were actually more opportunistic infectios in the placebo group than in the Prolia group.
What impresses me most about this drug is its safety profile and its ability to decrease fractures, while also significantly increasing bone mineral density. I also put my mother on it as soon as it came out.
Again, I am a big fan of yours, but you really need to spend some time immersing yourself in the science and talking to people who have in-depth clinical knowledge of a biologic before you write a review.
Vivian Goldschmidt, MA
July 16, 2010, 1:45 pm
I appreciate your comments, Tiffany. However, regardless of the studies conducted against placebos, common sense dictates that there will be some unlucky “patients” that will suffer from bad side-effects caused by this new drug.
To me, each person counts…I don’t look at the whole group as a statistical calculation, as these “studies” do.
The bottom line is that there is no question that Prolia (denosumab) tampers with the body’s immune system and with bone remodeling. And it’s not as though there’s no other solution for bone loss…
Let this be clear: I look at our biology as a whole ecosystem. Mainstream science isolates one health problem and attempts to invent miracle drugs to unnaturally correct it, at the expense of other important biological functions.
July 15, 2010, 3:34 pm
Dear Vivian,After aterrible reaction to Boniva.I would never try any drug.Commonsense eating and Vitamin K2 have helped me.No more drugs.Janet
July 15, 2010, 12:44 pm
Very interesting information so I thank you Vivian.
I have been following your acid/alkeline diet for one year now and feel great. I have just had a physical and have found out that my B12 is low from eating 80/20. Is this common?
Vivian Goldschmidt, MA July 16, 2010, 1:50 pm
Low B12 levels are usually due to a lack of intrinsic factor or low stomach acid levels. I recommend a B-complex supplement.
July 15, 2010, 12:22 pm
Thank you for your information. I consider it very valuable, as I choose to stop the fosamax program and boniva….just three years and I had all the bad side effects…..Glad to be rid of the drugs. Am diligent with diet , weight work outs, and exercise, and supplements. Will nownext yeat if I am holding steady…
July 15, 2010, 10:29 am
Thanks for the continued e-mails and your tenacity in researching the drugs and their potential side effects. I am a 5 year breast cancer “survivor” so I have endured some of the nastiest drugs imaginable as well as radiation. I stopped taking Boniva after one year due to the awful side effects. Your diet and advice have made a huge difference physically and mentally. I thought it would be difficult and time consuming; it is NOT! I want to tell everyone how easy it is to be healthier and stronger without drugs. Please keep sending your e-mails.
July 15, 2010, 8:33 am
I believe that the best way to prevent/stop & or reverse osteoporosis
is to engage in a Proggresive Strength Training program.The safest
& most effective is a “Super Slow” or Low Velocity strengthening
method.If Vivian or anyone has questions they can contact me at
email@example.com.Keep up the “good work”Vivian I am against
the use of alcohol & all drugs if not only for very rare instances of
life saving emergencies.Thanks Bert Vila Super Slow & Medx