This month's Save Our Bones Bulletin tackles news about osteoporosis drugs and the pharmaceutical industry. We'll examine newly published studies to ensure that you have the most accurate and up-to-date information about bone health.
First we'll look at two studies with opposing findings about the relationship between bisphosphonates and mortality risk.
Then you'll get the latest breaking news about a potential new osteoporosis drug.
We'll end on an encouraging note. The FDA is finally acknowledging that bone quality is an essential metric of bone health. Read on to learn more about how its policies are changing and much more.
Study Debunks False Claim That Bisphosphonates Reduce Risk Of Premature Death
A pair of studies released earlier this year concluding that bisphosphonate use reduces mortality risk have been proven wrong by a meta-analysis. The latter is a report that compares the findings of a large number of existing studies.1,2
The first study compared the lifespan of 6,000 individuals, divided into groups of bisphosphonate users and non-users. Based on that comparison, the researchers concluded that using bisphosphonates reduced the risk of premature mortality by 34%.1
A follow-up study looked at the same data to consider the relationship between bone density and mortality risk. This study concluded that 39% of the reduction in premature mortality risk was due to a lower rate of bone loss.1
However, a meta-analysis of 38 studies on bisphosphonate use completely contradicts the above studies, concluding that bisphosphonate use does not confer any benefit to mortality risk.2
Relevant Excerpt:
“The meta-analysis included 38 randomized placebo-controlled trials involving a total of 101,642 individuals, of whom 56,048 were treated with a pharmacologic therapy for osteoporosis while 45,594 were given placebo.
There was no significant difference in mortality rates among patients given an osteoporosis drug versus placebo, neither when all drugs were evaluated together (rate ratio [RR]=0.98) nor when the analysis was restricted to 21 trials of bisphosphonate treatments (RR=0.95).
Similarly, mortality rates were not significantly different among patients treated with zoledronate compared with placebo in six randomized trials, but Cummings et al note that “there was evidence for heterogeneity of the results.”The current findings “suggest that observational studies reporting that patients receiving bisphosphonate therapy had lower mortality may not have measured confounding factors that may have contributed to lower mortality [risk],” they say.”2
The researchers of the pair of studies mentioned earlier failed to consider that their results were skewed by neglected factors. This mistake illustrates why any single study isn't enough to draw a clear conclusion. It's important to seek out high-quality studies with results that have been confirmed by further research.
Synopsis
A pair of studies that concluded that bisphosphonates reduce mortality risk were proven to be incorrect by a meta-analysis of 38 other, higher-quality studies.
Potential New Osteoporosis Drug In Research Phase
A research group at Duke University has isolated a compound that they intend to chemically reproduce in an attempt to create a new osteoporosis drug. It is called adenosine, and while we already knew about this compound, researchers have uncovered its role in osteoporosis. They performed studies concluding that adenosine encourages the production of bone, and that its levels decrease with age, and in particular with decreasing estrogen levels.
In experiments on mice, the researchers found that increasing adenosine levels enhanced bone production, but adenosine isn't a viable treatment.
Relevant Excerpt:
“The researchers then sought to see if they could undo the destructive effects of the disease by increasing the adenosine levels. Instead of pumping in adenosine itself, they injected a non-hormonal small molecule produced by Bayer that activates the A2B receptor.
Still, the challenge remains of creating a small molecule drug-specific enough to be free of side-effects. Adenosine is made naturally in the body and serves many functions that include neuron modulation and regulation of blood flow to various organs. Adenosine cannot simply be administered through the blood in an effort against bone degradation without flooding other parts of the body. Molecule specificity is key to minimizing side-effects.
At least with the A2B receptor singled out, Varghese and others can begin researching into ways to deliver activators that bind only to receptors in the bones. For example, one of Varghese's students has commenced methods to tether adenosine-like molecules to carriers that target bone tissue. Her lab is also pursuing a sort of bandage that can convey growth-supporting drugs straight to damaged or broken bones.”3
The potential side effects are already evident: brain damage and cardiovascular problems.3 The risk of those side effects isn't worth the expected benefits. The same is true of osteoporosis drugs currently prescribed. We already have natural treatments for preventing and reversing osteoporosis.
Synopsis
Researchers have isolated adenosine, a protein that encourages bone growth, but that decreases with reduced estrogen levels. They are attempting to synthesize a drug that will imitate the action of the protein on bone, but the potential side-effects of such a drug are unlikely to be safe or tolerable.
FDA Requires Bone Quality Assessment For Osteoporosis Drug Trials
On a brighter note, the FDA is finally recognizing the failure of osteoporosis drugs. After ignoring decades of clear evidence that osteoporosis drugs decrease the quality of bone, from now on the FDA will require pharmaceutical companies to conduct bone quality tests in addition to bone density tests as part of their drug trials.
Relevant Excerpt:
“In addition to the pharmacology and toxicology studies required to support development of a new drug or biologic, long-term nonclinical studies, including bone-specific pharmacologic and toxicologic endpoints to evaluate the effects on bone quality, need to be conducted in appropriate animal models,” FDA writes.
FDA says such studies are necessary due to concerns over long-term adverse effects of drugs on bone quality and because “there are no validated and reliable methods for the noninvasive assessment of bone quality in humans.”
The eight-page guidance finalizes a draft version issued for comment in June 2016 and includes minor changes to the agency’s recommendations for conducting bone quality studies as well as some reorganized sections.4“
The Save Institute has spent years disseminating scientific research showing that bone quality is a vital measurement of bone health that must be considered in addition to bone density. The FDA is sorely late in considering the full picture of bone health, but it's a step in the right direction. It remains to be seen if this shift will have a meaningful impact.
That's not the only change to current FDA policy in regards to osteoporosis. Below are the rest of the new guidelines:4
- For already approved osteoporosis treatments, additional animal studies may be required “depending on the level of scientific concern.”
- The final guidance lowers the initially recommended number of drug dose levels that should be investigated in the bone quality studies from three to two—a dose achieving an optimal pharmacological effect and a high dose. The low dose option will be optional.
- Clinical treatment study duration for animal trials is recommended to last the intended duration- adjusted for the difference between animal and human bone remodeling cycles. However, the final guidance still provides species recommendations that only equal three years of human exposure.
- Recommends that bone quality studies should be conducted in two animal species for drugs, and a single study for biologics (which are drugs derived from living organisms)
- For postmenopausal osteoporosis, bone quality studies are recommended to be conducted in ovariectomized rats and a larger ovariectomized nonrodent species.
Synopsis
The FDA will now require drug manufacturers to test their drugs' impact on bone quality, in addition to bone density.
Ignore The Drugs To Improve Your Bone Health
As Savers know, the best way to increase bone quality doesn't require FDA approval because it isn't a drug at all: it's the actions you take every day. That's why we created the Osteoporosis Reversal Program.
Instead of risking side-effects and, ironically, causing a loss of bone quality by taking drugs, choose to follow an 80/20 pH-balanced diet and practice bone-strengthening exercises on a regular basis.
These easy lifestyle changes will do more than just improve the quality of your bones- they will improve your overall well-being and quality of life.
Stop Worrying About Your Bone Loss
Join thousands of Savers from around the world who have reversed or prevented their bone loss naturally and scientifically with the Osteoporosis Reversal Program.
References
1 https://www.sciencedaily.com/releases/2019/08/190812155456.htm
3 https://www.ibtimes.com/protein-could-reverse-bone-damage-osteoporosis-found-2817830
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Kombucha is rich in healthy probiotics that, among other things, have been shown to enhance bone density and protect the body from toxins, including GMOs. Because it is fermented, it is mildly acidifying, but you can certainly drink it with alkalizing foods to balance your pH. Enjoy!
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An article appeared in our local paper and it was about the awarding of the Liley Medal to researchers who had been given zoledronate and others a placebo. This has been ongoing for 8 years and is in a paper in the New England Journal of medicine. It does not say where the funding for this came from. It can be found on http://www.stuff.co.nz. It gives a glowing reference to the drug which alarms me.
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I have missed you. Bought your program a few years ago and used your diet and weight bearing exercises to strengthen my bones. However, two years ago I had a massive stroke followed by subsequent episodes. Sadly, I am partially paralyzed and unable to exercise. My BMI is below 21 but I nevertheless would like to be able to exercise. I look forward to your newsletters. Thank you.
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Thanks for sharing your story with us, Cynthia. So sorry about what happened… we admire your strength and desire to exercise. Stay well and keep up your great attitude!
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After 2 years of doing my best with ph balanced 80/20 diet and exercise as well as supplements…Calcium citrate, D3,K2,magnesium and more….my bones worsened considerably. 😔 I have recently switched to Algae based calcium and Strontium…maintain other supplements and continue doing what I can with diet and exercise. I don’t want to spend another 2 years ‘trying’ only to have worsening condition and feel I have no other choice but to do medications. I feel defeated…but, certainly appreciate all I learn from this site!
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Karla, please remember that there’s more to bone health than just density. The Medical Establishment focuses on it because the drugs (attempt to) address that aspect of bone health. As explained in the ORP, tensile strength and bone quality are critical to fracture prevention.
You can read more about this very important topic here:
https://saveourbones.com/6-easy-ways-to-boost-a-major-bone-matrix-component-that-prevents-fractures-the-medical-establishment-completely-ignores-this/ -
Hi Karla – how is your new regimen working? I just started the same program I think. Good luck!
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I’m in the same boat having exercised and watched my diet, adding in all correct supplements for a year I have recently had a hip fracture as a result of spontaneous fracture of the knee and further spinal compression. Lots of pressure now to go to pharmaceuticals. I’m only 68 and was very active. I’m unsure what to do.
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A parathyroid tumor can cause worsening osteoporosis. Good information about this at parathyroid.com. It is from Tampa FL, where I had my parathyroid tumor removed. An endocrinologist can diagnose this.
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having been on forsavance for 4 years when my legs gave from under me I have now given it up and would not recommend this drug I have recovered to some extent whish I had as much information when I started this as I have now
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Keep up with the Program, Rosie. You’ll see that your condition will improve as time goes by.
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Hello Vivian,
Two years ago I was diagnosed with Osteoporosis of the spine. It was recommended that I should start taking Actonel. I decided that I did not wish to take a drug after researching side effects. I am a great believer in taking responsibility for me own health as far as possible and so tend to avoid drugs unless proven to be essential.
During my research I cam across your website and bought two of your books online. These fitted so well to my own way of thinking. I upped my calcium level, which was necessary as I had lapsed on taking this for a few years and increased weight bearing exercises. I am careful about diet and have been for years but am not able to stick to your percentage quota but the general principal aligned with my dietary habits of Acid/ Alkali. One year ago I went for a repeat Bone Density Scan and my bones had improved. Today I had a yearly repeat scan and I have stabilized and not deteriorated. My spine measurement is overall -2.5 and my hips are unchanged with no osteoporosis.
My Specialist is very pleased. he told me that W.H.O. now only considers women who have osteoporosis in their hips to need drug help.
Thank you for being a constant source of support and backup while I chose to walk my own drug free path. I read all your newsletters and find them very helpful and have directed others to your website.
with love
Fiona-
Excellent news, Fiona! I’m glad you’re part of the Saver community and thank you for your kind words 🙂
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Thanks for letting us know that at least the medical community is recognizing that we are being offered drugs that even if they worked on bones ruin your overall health. I’ve been told my osteoporosis is so severe that I need daily shots for two years then must maintain with fosamax or boniva for life or lose all the benefit of two years of 1800.00 a month drugs! No thanks. Lift those weights!!!!
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Well said, Kathy!
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Compare Algaecal to Garden of Life Grow Bone System ingredients… they are pretty similar. Taking Garden of Life Grow Bone System my DEXA Scan increased slightly. I wont take prescription “osteoporosis” drugs ever. Do your own comparison and choose what you are comfortable with. Certainly a quality diet and exercise is right.
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What is your opinion regarding osteogenic loading? A few places called osteostrong are located near my place and I decided to try it but would like your opinion Vivian
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Jackie, osteogenic loading refers to the stimulation of new bone growth and absorption of minerals via axial loading of the skeleton. Axial loading is the application of force along the longitudinal body axis (the top of your head through your hips).
Osteogenic loading should be an integral part of a bone-strengthening workout. Osteostrong applies those principles, but you can also do that at home. Here are a couple of exercises you can add to your workout routine:
https://saveourbones.com/weekend-challenge-multi-tasking-osteogenic-loader/
https://saveourbones.com/weekend-challenge-enhanced-osteogenic-loader/
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Vivian, your weekly news letters are significant in educating those of us with osteoporosis and finally, the medical field, too. Her researched information has strengthened my resolve NOT to take prescription drugs for osteoporosis. I am pleased with today’s notes that drug testing will include bone quality. How will they test it is my question? You are a valuable resource for my knowledge in “saving my bones!” Thank you for your dedication in educating us, Vivian.
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You’re very welcome!
To answer your question, in a draft prior to the final determining statements, the FDA has written this about testing for bone quality:
“Although bone quality cannot be easily assessed directly, nonclinical studies offer the opportunity to develop indirect information about bone quality through the measurement of bone strength, which is determined by both bone mass and bone quality.”
They did not develop the topic further but rest assured that we will keep you abreast of the latest news on this.
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A few years ago my arthritis doctor gave me 2 injections of Prolia (6 months apart). What I didn’t know in advance is that this can cause femur fracture. The research on it states so in very small print, I learned after the fact. Anyway, I developed a femur fracture that led to bone necrosis, that collapsed, and I ended up with emergency hip replacement surgery.. So everyone should be wary of this class of drugs. They are very dangerous! Before letting your doctor prescribe this, read up on it first and learn about the dangers.
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I’m sorry that you’ve experienced Prolia’s awful side effects, Helen… I hope your surgery went well and that you’ve experienced a full recovery.
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Questionable drugs with sometimes serious side-effects – or an 80/20 pH-balanced diet along with regular bone-strengthening exercises. To me the choice is a no-brainer! But then I learnt my lesson after allowing my GP to give me one Prolia injection. Never again! My advice – ALWAYS read the small print before agreeing to any medication.
Ann Johnstone-
Thanks for sharing this and so glad to know you only had one Prolia injection, Ann!
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How long does it take to get Prolia out of your system? I am having trouble finding information for recovery. Thank You.
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I have noticed there are numerous alkaline/acid food charts and all of them vary quite a bit. It’s a little confusing to follow. There are too many foods in different categories to bother mentioning them all, but I was looking specifically for kombucha and wondering if that is alkaline- or does it at least produce alkaline ash. Thank you for any insight.