The race for new osteoporosis treatments is on, as Big Pharma is desperately trying to find new patentable drugs. And, as further confirmation of the disastrous failure of current treatments, a popular osteoporosis drug touted as the “safest” of all is on its way out, as I predicted from the get-go.
So let’s get started!
Desperate Search for New Osteoporosis Drugs as Existing Drugs Fail
The Foundation for the National Institutes of Health has recently announced the launch of a 3-year study to look more closely at osteoporosis. The intent of the study is to develop “more effective treatments” for osteoporosis.
“The study, which utilizes data from existing academic and clinical trials, is designed to establish the validity of specific imaging and biochemical markers for bone health.
Approximately 9 million adults in the United States suffer from osteoporosis … with our aging population, the numbers continue to rise. Over the last twenty years, progress has been made in both the diagnosis and treatment of osteoporosis. Substantial challenges remain, however, including … efficacy of a given treatment beyond the duration of most clinical trials. Recent concerns have prompted regulatory agencies to review the safety of antiresorptive drugs for osteoporosis, while these same concerns among patients and physicians are decreasing the use of this particular class of drugs.
“ ‘There is an imperative need for continued development of new osteoporosis drugs and for determining rational clinical strategies for their use,’ says Dr. Janet Woodcock from the Food and Drug Administration (FDA). ‘We applaud the FNIH for spearheading this important work.’” 1
I find it fascinating that the Medical Establishment and the media continue to tout “progress” in treating osteoporosis, yet in the same breath they talk about how the number of osteoporosis cases continues to rise.
Think about this for a moment: if current treatments would be successful, there would be no need to develop new drugs… So in essence, the Medical Establishment is recognizing their failure.
Also when faced with concerns about the dangers of current osteoporosis drugs, the medical and pharmaceutical answer is to develop more drugs.
Here at Save Our Bones, we draw a different conclusion: concerns about osteoporosis drug safety should be taken seriously, and valid, effective, drug-free solutions like those described in the Program are the safest and best option.
Amgen’s “Positive” Romosozumab Study Shows a Clear Conflict of Interest
Amgen is announcing the results of a recent study that shows its new drug, romosozumab, increases bone mineral density (BMD) in postmenopausal women, especially when compared to Fosamax and Forteo.
“Romosozumab is an investigational medicine in phase III clinical development for the treatment of osteoporosis in postmenopausal women and is not currently approved by any regulatory authority. Romosozumab is being co-developed by Amgen and UCB.
In this phase II trial, each of the five romosozumab dose regimens significantly increased BMD compared with pooled placebo groups at the lumbar spine, total hip and femoral neck regions (all p<0.001). The largest increases were observed with the romosozumab 210 mg once-monthly dose, with mean increases compared with baseline of 11.3 per cent at the lumbar spine, 4.1 per cent at the total hip and 3.7 per cent at the femoral neck. Additionally, in exploratory analyses, BMD gains were significantly greater than active comparators at month 12, with romosozumab treatment achieving a mean increase of 11.3 per cent at the lumbar spine compared to increases of 4.1 per cent and 7.1 per cent at the same region achieved with FOSAMAX and FORTEO, respectively. At the total hip, romosozumab treatment increased BMD 4.1 per cent, while observed gains with FOSAMAX were 1.9 per cent and with FORTEO were 1.3 per cent (all <0.001).1.” 2
Interestingly, several of the study’s authors revealed financial ties to Amgen and UCB Pharma. In addition, the study itself was funded by these drug companies. So the researchers had a strong financial interest in presenting romosozumab in a positive light.
As Savers know, romosozumab’s mechanism of action is the suppression of a protein called sclerostin. Sclerostin’s role in bone remodeling is to regulate the formation of new bone; it temporarily stops the formation of new bone so old bone can be shed.
Like many osteoporosis drugs, romosozumab may indeed increase bone mineral density; but the problem is, this is achieved artificially by suppressing the body’s natural remodeling process. The bone then becomes hard and brittle, and more prone to breakage. Romosozumab is no exception to this bone-damaging rule.
The study also reported adverse side effects in the participants, including upper respiratory tract infections, back and joint pain, and headaches. “These reactions did not lead to study drug discontinuation or study withdrawal; the safety of romosozumab will be further addressed in subsequent larger studies,”2 the authors note.
In other words, the safety of this new drug has not even been tested yet…which leads us to our next news story about the vacillation between “safe” and “risky” labels on osteoporosis drugs.
Safety of Protelos Called into Question
The European agency PRAC (Pharmacovigilance Risk Assessment Committee), which is the equivalent of the FDA in the United States, has recommended stopping the use of Protelos (also marketed as Osseor, Bivalos, Ossum, Protos, Protaxos) for treating osteoporosis. This follows on PRAC’s recommendation to restrict the drug’s use back in April 2013.
“…the PRAC risk assessment committee of the European Medicines Agency (EMA) said the risks of serious heart problems, including heart attacks, blood clots and blocked arteries, were just too great.
For every 1,000 treated patients, there were four additional cases of serious heart problems and four of clotting among people using Protelos/Osseor compared to those given a placebo or dummy treatment.
Other risks include seizures and liver inflammation.” 3
According to PRAC, any “benefits” of Protelos are outweighed by the known risks. Of course, these risks were known long before by those on the Osteoporosis Reversal Program.
I warn of the dangers of Protelos in the Osteoporosis Reversal Program:
“Protelos has its own list of side effects. During clinical trials, the most common side effects were nausea, diarrhea, headaches and skin irritation. Other quite dangerous but fortunately less commonly reported side-effects were blood clots, fainting, memory troubles and, in rare cases, seizures.”
Protelos is composed of the mineral strontium combined with the synthetic chemical ranelate. It was initially considered a “safer” drug because of its basis in a natural mineral, but as mentioned earlier, it’s most certainly not so.
Strontium ranelate competes with calcium and is a bone thickener rather than a bone strengthener. In fact, as mentioned in the Osteoporosis Reversal Program, studies have confirmed that only the outer cortical bone becomes thicker, thus compromising tensile strength.
Instead, bones can be strengthened naturally via diet and exercise as described in the Osteoporosis Reversal Program. It just doesn’t make sense to risk the dangerous side-effects of osteoporosis drugs.
Till next time,
1 “Foundation for the NIH Launches Bone Quality Project.” PR Newswire. December 5, 2013. Web. https://www.prnewswire.com/news-releases/foundation-for-the-nih-launches-bone-quality-project-234586531.html
2 “Amgen, UCB announce phase II trial of romosozumab in postmenopausal women with low bone mineral density.” Pharmabiz.com. January 3, 2014. Web. https://www.pharmabiz.com/NewsDetails.aspx?aid=79605&sid=2
3 “Europe watchdog advises suspending ‘risky’ osteoporosis drug.” TheNews.com. January 11, 2014. Web. https://www.thenews.com.pk/article-133773-Europe-watchdog-advises-suspending-risky-osteoporosis-drug
Comments on this article are closed.
This is opposite of what you wrote, that “it temporarily stops the formation of new bone so old bone can be shed” and “bone then becomes hard and brittle, and more prone to breakage. Romosozumab is no exception to this bone-damaging rule.
This drug makes lots of bone grow (like those with sclerosteosis or van Buchem disease (https://en.wikipedia.org/wiki/Sclerostin#Clinical_significance).
How do you live with yourself? You are SELLING a program, entirely ignoring the efficacy of medications proven to provide a dramatic reduction in fracture risk. When you go ahead and publish a well-designed controlled trial of your program that shows reduction in fracture risk, maybe then you can talk. But it is positively maddening that someone with a financial interest can go ahead and – very convincingly for a layperson – “discredit” some excellent science with what is a pretty terrible and misleading outlook. Shame on you. Shame on you. Shame on you. I spent 2 years getting a masters, 4 years in med school, 3 in residency, and 3 in fellowship. I have ZERO financial incentive in prescribing osteoporosis drugs. I’m a salaried physician, so really – ZERO. But I HATE the fact that I spend hours talking to patients until I’m blue in the face and they’re all convinced the “Medical Establishment” as you so condescendingly put it is out to get them and don’t take meds that could be very helpful – when used correctly for appropriate intervals. Such as bisphosphonates at up to 5-10 years of use, depending on the INDIVIDUAL circumstances. Instead they have calcium and exercise and fractures. Seriously don’t understand how you live with yourself. Please go take a good long hard look in the mirror, and then quit.
Get over yourself and read the research on why most of us are not willing to take these big pharma $$$$$ drugs. They are equally or more dangerous that the scare of frail bones and fractures. There are valid reasons to be anti medical establishment. You can fix broken bones buy you don’t know much about the true healing nature of bones. Or, you wouldn’t push Fosomax. Sorry you chose the wrong profession. You could do well to balance your pill pushing education with more naturopathic healing modes.
I don’t have any dogs in this fight, but I’ll go with the doctor over the layperson any day. Score: Doctor 1, Vivian 0
I have read that you must not take a vitamin & mineral supplement with iron in it. How do you feel about this Vivian?
My Doctor has prescribed Fosamax for me twice now and I just won’t take it. I went to see a Nutrishionist in my area and had a hair test done to check the levels in my system. I started taking Vitamin D along with Magnesium and Strontium Citrate. My Dexa scan went from – 3.1 to – 2.7. I will continue trying this since I refuse to take the poison that they recommend.
I am 63 and have been treated for osteoporosis for years starting with Fosamax for I don’t know 15 years then injectable forteo for 2 years . Dr immediately wanted me to go on Prolia. I said STOP. I am focusing entirely now on my body. Building strength and balance through exercise. Yoga . Nutrition and a new method of weight training called OSTEOSTRONG. Google it. They guarantee increase of bone density after one year …something my dr could not do. They are only in a few locations because it is new but expanding. Headquarted in Franklin Tennessee.
It will be a year in June. I decided to give my body a rest of any osteo medication and try this mind body approach. My osteoporosis is at the moment and as far as I know in one hip and in lower back with osteopenia pretty much all over. It would be nice to think the pharmas will eventually come up with safe and effective meds but for now I feel I’m taking the right approach. June will be telling. Everyone with osteo should be walking or moving someway everyday! And not drinking coffee .
My Dr is recommending Prolia. Is it good?
I’m 54 and have been taking osteoporosis drug Bonviva for almost 2 years. I think you are right, osteoporosis drugs will do more harm to our bones. I am really shocked and scared what you revealed. Everyday I feel pain on my back and I feel I must stop but I don’t know what will happen to me if I stop in the middle. What will be the effect? I have been worrying a lot and could not sleep. I would be very thankful for your kind advice.
I Stay Away From Osteoporosis Prescriptions. I Just Try To Eat Foods That I Know Are Good For My Bones.
Thank You For All The Research You Do For All Of Us.
Take Care, And Stay Well. All The Best To You And Your Family.
LOVE, LESLIE (MS. L. CARMEL)
I’m 60 years old and my density is -3.0 in the and -2.7 in the spine…..it was steady for two years at -2.7 and 2.9 and had improved 4% with weight lifting and exercising and trying to eat the right foods. I also have kidney stones.
My last BD was done in Sept. of 2013 and went down some. Do you think it’s too late to improve my bone density at my age considering the latest results. There is no history of osteoporosis in my family. I’m a little worried!
We have been following “Save Our Bones” program in recent years(2-3) , but my husband’s Dexa Scan has moved from Osteo-penia into Osteoporosis, so intensified Rx with addition of Andro-Gel for progression of Low T in recent years. I have read much of your Blogs in recent years, but not seen any Mention of your DEXA SCAN values since the Initial improvement you had on the”Program”. Can you fill us in on the continued changes over time, as this will strengthen our
discussion of same with our Drs. Thanks for your REPLY, Vivian
as we closely follow your guidance in this nutritional program.
I took Bisphosphonates for several years, mainly because both of my parents had Osteoporosis, my mother’s was severe. I discontinued the Bisphosphonates a couple of years ago. My last bone density showed I had Osteoporosis of the Lumbar spine. Do you have any suggestions as to how to get these drugs out of my system? I also have a history of kidney stones ,which is the reason I have been eating a alkaline diet for years.
People suffering from Diabetes receive insulin artificially, which enables them to continue to live and function. I wonder if it’s possible to come up with a drug which will supply osteoporosis women with the missing chemical or protein or other that enables healthy people to produce enough osteoblasts, in the right time, for the right length of time.
I read an article on a “benefits-of-honey” website “Is Stevia Safe.” They referred to “crystallized” stevia as a highly processed plant extract found in most “supermarts.” The scary part was “some researchers suspect this modification could mutate DNA and cause cancer”. Then there’s a place to buy the “Better Stevia” (actually a brand which I’m sure is also processed. I’ve been using Stevia about 2 years in the powdered packets. Thought I saw FDA had approved its use–does that mean it’s safe?
I have been given Strontium Citrate for Osteo…I take 1 a day (227 mg) (Vit C . 20 mg). I also take a liquid Calcium and Magnesium, Vit D3. I’m wondering if Strontium actually helps renew bone growth or just hardens the outer layer of bone?
Your imformation is always good and inlighting. The book has helped me to improve my overall health. THANKS INELL
About 10 years ago I took Evista. During that time, I looked up info on osteoporosis and discovered Vivian and Save our Bones. After the next Dexa scan the doctor said I needed something stronger than Evista and wrote a prescription for Fosamax. I never took it. Thank you, Vivian.
Just recently, I got off balance and fell (a hard sit-down fall) Results: sore back for 3 weeks, gradually improving but no broken bones, Also, recently I stopped taking calcium made from stones to calcium made from algae. Thanks to your info Vivian. Purchased it thru your web site. I just ordered more and found out I could get the same discount if I mentioned “Save our Bones” when reordering.
I have a friend who can’t take calcium citrate because she develops kidney stones. I will forward the information to her. She has already quit drinking milk and switched to almond milk and loves it.
It would be interesting to really understand how is it that osteoporosis or weak bones are so prevalent. Van Buchen disease is a genetic defect which renders sclerostine ineffective, hense these poor people having the disease have their bones overgrowing, causing nerve pinching, and among other severe ailments, deafness.
Are their bones weak ?
Also we could learn a lot from history, quite a few rich people in the 19th century had bad diets (lots of sugar), little physical exercises (work done by servants).
I agree fully to avoid these horrible drugs, yet it would be nice to find more about the osteoporosis. Even if a good diet and proper exercises help, some still have fractures.
I am not criticizing, I have severe osteoporosis and refuse all drugs. I increased bone density the first year, but it remain the same afterwards.
I was given Evista & I took it for about four months…..I could not tolerate any sunlight or heat….terrible painful rash, it took about six months after stopping to clear my problem.
In 1987 was the collapse of my first vertebrae and the start of various drugs. I’m now 86 and cannot remember the names of the drugs but nothing helped. In 2012 I started eating chia and hemp seeds and to me they are doing the most good. I also have been drinking since 1996 1/2 glass apple cider vinegar. Last year my doctor suggested for my osteoporosis aclasta which is administered by intravenous and is done once a year. I read all your very informative articles but have never seen you mention aclasta. In 2012 I had cement injected in my spine.
I am taking a soy-based dietary supplement called Fosteum. Do you have any research or opinion about it, Vivian (or anyone?) My bone density has increased over the years, and I attribute a part of that to Fosteum. Should I?? Thanks for an informative and provocative site.
Wow Vivian!! Great information. It always amazes me when companies put out their own reports as “the only conclusion there could be” thoughts implied. To be honest with you, I think I’ll start praying for all of those on the trial and pray they will find your site. I have a new friend asking questions as her family has osteo problems. I have to go slow even talking to her about it as she is defensive about maybe doing the wrong thing for so many years. Making progress and as soon as she is open to hearing the truth I will send her to your site. You are the best and thanks for all the encouragement along the way!!!
I have been taking Evista for many years for my bones. You don’t mention this drug in your article. Should I be taking something else?
I am 71 years old.
So glad for your updates. My doctor is resigned to my stance on drugs and doesn’t mention it anymore. Wish doctors were getting these research summaries so they could know about it.
By the way I’m usually good at pronouncing words but romosozumab has me challenged! Thanks again for the info.
Vivian, what is the brand name of the shower head you recommended to clean up my showers?
and thanks for all the bone info
I did the 26 month program of Forteo even considering the risks involved because of early osteoporosis being familial, & having a complete hysterectomy at age 22.
One month following the completion of Forteo, I was given the diagnoses of osteopenia. One year later the osteoporosis was back with a vengeance after having another dexa scan. I don’t recommend Forteo to anyone! None of the other bone building drugs worked for me either, & my doctor had me try them all! Have had many fractures as all my aunts & mother did too. Thank you Vivian for having this site! It’s been an eye opener for me.
Thanks for the update on osteo drugs, Vivian. But you beat them to it years ago!
hello, just wondered why the role of zinc is so often ignored in treatment of osteoporosis, also the fact that most beings over the age of 50 years will have some form of achlorhidria /hypochlorhidria which will obviate their ability to absorb most minerals and many vitamins from their diet. Possible low zinc intake may initiate and perpetuate this problem. I would be most interested to hear your views. I follow your newsletters avidly and think your research and education is excellent.
I took Protelos for about two months a few years ago. One of the reasons I stopped taking it was it was loaded with aspartame – it was sickly sweet.
So I changed to strontium citrate, which didn’t need a prescription. Then I came across this site, read more, and stopped it altogether. So glad now that I did.
Thank you Vivian for all your help!
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