update: THE END OF PROT(E)OS: TAKE NATURAL STRONTIUM SALTS [not the synthetic RANELATE-PROT(E)OS]- AGAINST OSTEOPOROSIS, CARIES, ARTHRITIS..

UPDATE 10 January 2014:  PROTOS SUSPENDED -another snakeoil bites the dust- strontium ranelate. It has apparently never been registered in USA anyway.

EU Panel Recommends Suspension of Prot(el)os/Osseor

Miriam E. Tucker  January 10, 2014

This does not affect the physiological use of natural strontium salts as one of a score of natural bone anabolic elements along with the other essential minerals, vitamins proteins and hormones  in our Milieu intérieur  .

neil.burman@gmail.com

update 11 Dec 2010

once again, a relevant comment from a reader (qv Doris Bevans below) prompts an update- and a title revision. The risk  is not strontium, but the patent designer drug Protos/Proteos /Protelos – strontium ranelate- ie as this column has stressed from the start, it appears to be the synthetic anion ranelate that is the problem, not the metal cation  strontium. This is similar to the sodium situation, where it is the anion chloride in table salt that is mostly the hypertension- fluid retention problem, not sodium.

These strontium comments by users  mostly generalize- as this review has- about  strontium . But of course as a useful comments website  shows, there are many natural salts of strontium in use.

The focus of this strontium review column the past three years has naturally been on the potentially hazardous designer patent drug Proteos, Protos, Protelos  strontium ranelate StRan – for which there is absolutely no need considering the numerous perfectly safe and multisystemically  far better alternatives.

Perusal of Google makes it obvious that  StRan is not a natural salt- in fact there is no mention of ranelic acid or strontium ranelate  (Sr2SN2O8) until some 20 years ago when someone first created it-  to enable patenting of a strontium salt for osteoporosis. Imagine how long industrial chemists must have schemed to find a new molecule to carry the useful strontium cation? But the story has apparently yet to be revealed on the internet. One can only speculate why the story of it’s invention has not been put on the internet.

But the common earth metal  strontium was already ‘discovered’ over 200 years ago  – in Scotland-   and has numerous industrial uses  as diverse natural salts. Ward Dean MD points out that strontium salts have been used medicinally for well over a century-  against osteoporosis but especially painful cancer in bone, against dental caries and arthritis; with the optimal dose apparently around 600mg strontium a day.  Usefully, this is about the same optimal dose as calcium, since  as Dean says   “a  comprehensive regimen of synergistic bone-enhancing substances should provide the optimum regimen for preventing and treating osteoporosis. We know that obviously the optimal regime includes  appropriate sex hormones.

So far there  are at least twelve agreed biologically valuable  metal(oid)s  ie cations for humans:  sodium, potassium, calcium, magnesium,  iron, zinc, copper,  boron, manganese, chromium, molybdenum, chromium, vanadium, cobalt; and arguably lithium, gold, silver, silica and nickel.

However, no-one has yet   shown that strontium  is an essential (trace) element like the recognized lighter metals.. .

But just as lithium salts were recognized to have major multiple medicinal benefits within 50 years of discovery ( by the mid 19th century),  natural strontium salts have been recognized and promoted as useful for osteoporosis prevention and management since at least Shorr and Carter 1950 .

And of course the designer StRan  has still not been registered for use in the USA. The detailed data sheet for strontium ranelate warns chillingly of its deadly risks of venous thromboembolism and dermatitis; that it contains phenylalanine;  and that it confounds calcium level measurement.

So the glowing testimonials by consumers to the benefits of strontium salts in USA can only be from the use of natural strontium salts there, unless Protos/Proteos was brought into that country by patients.

And indeed, there do not appear to be any adverse effects to natural strontium salts used in sensible dose the past century.

Rousselet ea showd already in 1975  tight feedback regulation between calcium, strontium and vitamin D:  “Oral administration of strontium to calcium wellfed rats blocks intestinal absorption of calcium. When high doses of vitamin D are given over long period, the inhibition of calcium intestinal absorption disappears. Under these conditions the absorption of strontium is increased. It is suggested that there is only one absorption mechanism for these two cations. An overdose of vitamin D increases the renal elimination of strontium but under these conditions the plasma concentration of the strontium is unchanged. Vitamin D brings about the same action on  bone fixation of the strontium as it does on  bone fixation of calcium. Bone fixation is increased with low dosages,  decreased with high dosages.”

So like lithium and silica, there is no apparent reason not to use moderate  doses of  natural strontium  salts orally in supplements.

Phosphates are indeed , like zinc and  copper , calcium and magnesium, biologically essential in the right balance. It looks like strontium may be the same. .  But that doesnt make the synthetics bisphosphonates or strontium ranelate safe- indeed they may cause deadly complications. So why risk them when the only winner is the manufacturer?

And this time the FDA has been wise to deny registration of StRan. As a designer drug it is not in the category of lithium and metformin, enormously beneficial drugs in recommended doses which the FDA denied  without reason to Americans for at least 20years, (except could it have been to protect their own drug company profits?) costing vast numbers of lifeyears and lives.

Hence in future correspondents praising strontium  need to state what form of strontium they are taking.

update 14 November 2010

Crystal comments today: “My mother has taken strontium Sr for the past 2 years and her bone density from her last bone scan has improved greatly.  I am a believer!

Dear Crystal,

Assuming you are talking about the topic of this column- strontium ranelate-  is that  great? I am also a believer in faith and prayer; but  faith doesnt prove anything  objectively, in fact it still leaves  billions starving and in abject poverty, and  all of us in major jeopardy from mankind’s madness, greed and  ruthlessness .

If doctors  rely on faith,  prayer and Big Pharma, regulators- not  critical evidence, common sense  and experience  – heaven help Mom, all patients.

Improvement in bone density doesnt translate into longterm benefit, healthy  longevity.  What real benefit is strontium  ranelate having for Mom, on fracture rate, muscle ie strength, and all other aging systems?

The biggest risk for osteoporotic fracture is not low  DXA bone density (a very profitable designer hi-tech technology that irradiates patients totally unnecessarily)  but failing muscle, co-ordination, balance- for which strontium apparently does nothing.  Overall, the top disablers and killers  of old age are  not fractures but vascular disease, cancer, dementia, strokes.  At no age do fractures appear in the top 10 causes of death in the USA.
And there is still no evidence of StRan’s longterm SAFETY- in fact the potential risk of the DRESS syndrome makes strontium ranelate contraindicated when the proven safe more-than-twenty  natural proven  bone multinutrients that greatly improve all systems are so effective and available.

Why take a snakeoil designer drug like Proteos when natural works both better and safer?
Look at how bisphosphonates improve bone density- but at terrible multihazard risk of  later disaster –  teeth and jaw loss, fractures from harder but more brittle bones, skin & gullet complications.

Why risk  strontium ranelate’s “memory loss and diarrhoea during longer-term treatment” (Deeks ea 2010), or venous thromboembolism (Osborne 2010) .    And in a massive study, Guerra-Garcia ea 2010 have just shown that over the 5 years 2004-2008 in 12 000 patients, the prescription of  StRan  has risen 10fold and bisphosphonates 50%- but without reduction in the incidence of hip fracture.

Yet the current Wiiki entry on strontuim ranelate still omits the horrendous risk of the DRESS syndrome; and still tells the lie that the drug reduces hip fractures by a third. Presumably  the StRan  manufacturer Servier uses Wiki as its carefully sanitized advertorial.

Focusing just on medium-term fracture benefit (up to 5-10years) and ignoring all-system benefits and risks,  is absurd negligence- the criminal deception practiced by Big Pharma and blissfully ignored by the FDA and the leading journals and “expert reviewers” who depend on big pharma’s  handouts .

Appropriate natural supplements reduce  premature ALL-CAUSE disease and deaths by almost half.

If you are taking StRan, you and your doctor have conned yourselves, as intended by  Big Pharma, ( the Disease Industry and the Governments- politicians- who  are well paid to  support  their Disaster Capitalism ) . Only Disease Pays. And worst of all, they have conned you  into taking potentially lethal costly poison that does  overall no good. Has anyone checked her height, her spinal xray, her memory, bloodpressure, carotid calcification, kidney function  to show that these markers  havent deteriorated  despite StRan?

Drug companies NEVER allow the true adverse effects to be published in their fabricated trial result reports – thats why the big mafia companies  – Pfizer, Bayer, GSK- are fined $billions every year. They could care when a raincheck con like Proteos, a statin, a Vioxx  or a fosamax can bring them a few-score $billion in profits in the years before it is canned due to increasing patient disasters. They simply budget into the price patients pay for  the fines and litigation, and the few million in compensation they pay out for the disasters since American law deliberately PROTECTS them, as it did in the biggest medical scam ever,  the Swine Flu swindle  of 2009. And in 2010 the even bigger  Professor Scott Reuben scandal -over which Pfizer and Bayer get off scot free.. .
No new trials have been published the past few years to justify the use of StRan as being superior to other snakeoil designer drugs designed for osteoporosis, let alone against multipurpose natural preventatives.
This confirms the destitution of Big Pharma.
 No chronic synthetic drug of the past 40 years has been shown to reduce  premature ALL-CAUSE major common disease and deaths as the basket of natural supplements does.    I will be delighted when another such  drug is discovered- as the 90year old natural plant extract metformin is, and fish oil  is, and appropriate HRT hormone replacement is. .

update: 22 Dec 2009:  on this radiant southern summer solstice day, there is no good news  on strontium ranelate because no new trials have been published in the past 19 months.

In their Cochrane Review of 2006, Reginster ea could find just 4 trials of strontium ranelate for  3 to 4 years ; these showed 37% fewer spinal fractures but only 14% fewer non-spinal fractures -results no-where near as good as with safe lowcost multisystem protection with appropriate non-oral human estrogen and testosterone, and vigorous dose of a blend of  calmag boron zinc manganese, proline,  the vitamins B6-9-12, C, D and K .

And as with SERMS eg tamoxifen, and bisphosphonates, why use StRan for osteoporosis  when there is better safer natural multisystem prevention and  treatment?  Severe complications may be rare (<1 in 10,000 cases) but as reported by Reginster ea,  except for the profit of manufacturers, why risk life-threatening reactions? – Stevens Johnson syndrome (SJS) and TEN toxic epidermal necrolysis with bisphosphonate,  but with StRan  TEN syndrome,   and DRESS – angioedema, drug rash with eosinophilia and systemic symptoms (DRESS), let alone renal failure and alopecia..

Again, Prescrire sums it up:  “Strontium: confusion and hallucinations. Do not use strontium”. We now acknowledge this should read strontium ranelate.

Only the crazy or the malicious  would recommend aspirin or designer anti-inflammatory drugs  (with their  major risks)  for mild to moderate pain  when paracetamol or, better, a simple safe mix of natural anti-inflammatory-analgesics would suffice eg MSM-curcumin-pantothenate-catsclaw-bromelain-boswelia.

Osteoporosis occurs mostly in the elderly ie those at far higher risks- osteoporosis is a late sign of multisystem deficiency risks, with patients far more likely to die from the concomitant other degenerative diseases – frailty, vascular, malignant, dementing- than from fractures .  So it is criminal to delay effective prevention till osteoporosis is present, then prescribe risky drugs like SERMS, bisphosphonates or StRan when far more multisystem effective and safe therapy has long been available and proven.

22 May 2008

The promotion of essential micronutrients like sex hormones, vitamins and minerals for multisystem health including bones is vital.

But what evidence for longterm cost:benefit is there for strontium ranelate StRan  for anything let alone bones?

A warning was published in 2005 (Prescrire Int. ) Strontium: new drug. Postmenopausal osteoporosis: too many unknowns. [No authors listed]). . No new trials have appeared since. .

There is in fact only one solitary major trial published of sodium ranelate  SrR in osteoporosis, the SOTI-TROPOS trial by Reginster,  Meneur ea for the strontium ranelate  SrR manufacturers (Servier) at 72 centers in 11 European countries and Australia, in some 5000 postmenopausal women recruited from 1996 through 1998 ie till about 2003, with either previous postmenopausal fracture or frank osteoporosis: All on 1 to 1.5gm calcium and vitamin D 400-800iu/day, they were randomized to placebo or StRan 2gm/day. After a mean of 3 years, compared to placebo, vertebral fractures in 1442 women at a mean of 69yrs were reduced by 49% from baseline , but in the entire cohort nonvertebral fractures were reduced by only 16% from baseline at mean age of 77yrs.. All fractures were reduced from 12.9% to 11.2% ie 4.3%pa to 3.7%pa; hip fractures from 3.4% to 2.9%, vertebral fractures from 14% to 7.7%.

Are these differences significant for patient care, when the longterm effects of StRan therapy are unknown, and the longterm adverse effects of biphosphonates are becoming horrifically clear?

But these trials of StRan used only weak baseline prevention of lowdose calcium and vitamin D . Numerous other preventative bone-and muscle-strengthening supplements were apparently specifically excluded or omitted – magnesium, estrogen. vigorous-dose vitamin D eg 2000iu/d, vitamin K, androgen, boron, zinc.
And like the concurrent Womens’ Health Initiative, the SOTI-TROPOS trial was stopped woefully too soon instead of letting it run for at least 10 years to see the longterm benefit (if any). Worst of all, it did not test whether StRan adds any benefit on a sensible baseline of all the proven supplements that we have used for decades.

As Winzenberg ea ask in a recent 2007 Australian review, Strontium ranelate Does it affect the management of postmenopausal osteoporosis? Strontium ranelate did not cause gastritis, back pain or death, but more or less doubled numerous adverse effects :
*50% more (ie six out of 100 women taking strontium ranelate) experienced diarrhoea compared to four out of 100 taking placebo,
• The risk of vascular system disorders including venous thromboembolism (two trials, n=6669, 2.2 vs. 1.5%, OR: 1.5, 95% CI: 1.1–2.1) , pulmonary embolism (two trials, n=6669, 0.8 vs. 0.4%, OR: 1.7, 95% CI: 1.0–3.1) * as well as nervous system disorders such
as headache (3.9 vs. 2.9%), seizures (0.3 vs. 0.1%), memory loss (2.4 vs. 1.9%) and disturbance in consciousness (2.5 vs. 2.0%) is
slightly increased with taking 2 g of SrR daily over 3–4 years
• There were no RCTs identified which compared StRan to other treatments of postmenopausal osteoporosis.”

It is common cause that the chief risk factor for fracture is not bone density but frailty, falls; and that the only microsupplements that strengthen muscle are apparently androgen, zinc, calcium and magnesium and the vitamins D3 and B6, 9 and 12. There is no absolute contraindication to appropriate long term human androgen plus estrogen replacement .

Now Fuchs ea show that “Strontium ranelate does not stimulate bone formation in ovariectomized rats” – sex hormones are necessary for strontium to benefit bones.

With the oldfashioned calmag, zinc, boron, fluoride ,vitamins A-E, and parenteral androgen plus estrogen, we have seen bone density rise by 1%pa and hip density by 1/2% pa over 15years from age 52 in a frail woman with severe rheumatoid arthritis, despite management with corticosteroid and other remittive drugs, and repeated surgeries to replace destroyed joints. She has never sustained an osteoporotic fracture.

So what is the indication to add the costly long-term (ie >10year) unproven strontium to proven effective supplements?

Strontium ranelate may work in the medium term (3 to 5 years) but there is still apparently no more justification for using strontium ranelate  routinely for preventing/ treating ageing osteoporosis than there is for biphosphonates or calcitonin.

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5 responses to “update: THE END OF PROT(E)OS: TAKE NATURAL STRONTIUM SALTS [not the synthetic RANELATE-PROT(E)OS]- AGAINST OSTEOPOROSIS, CARIES, ARTHRITIS..

  1. I think that you are dead wrong about strontium. If you check my blog at http://strontiumforbones.blogspot.com you will see that there have been a lot more clinical trials then you mentioned with positive results.

  2. Dear BoneLady,
    where ever you anonymously are:
    we would be delighted if you can let us have references to meaningfully sized controlled trials that show that strontium has both efficacy and safety when used for more than a few years. Please give us the studies that show it is remotely as good for reducing not just fractures (hip, spine etc) as the long-used safe and highly effective combination of a dozen vitamins, minerals and biologicals, but at the same time also reduce all common major aging diseases from infections and falls to cancer, vascular – dementing and arthritic diseases.
    The art of medicine is to prevent and treat ALL common degenerative diseases – not just one- so as to greatly reduce all morbidity and mortalty. Where are trials showing that strontium alone (with calcium-vitamn D) does this, or that adding it to the natural dozen supplements mentioned makes any diffenence?
    We will be delighted if you prove us dead wrong about strontium let alone Proteos.
    ndb, healthspanlife.com

  3. wow..awesome!! I found very helpful articels in here.
    Thanks for the sharing and keep posting. 😀
    BR
    Auliandri

  4. My mother has taken strontium 2 for the past 2 years and her bone density from her last bone scan has improved greatly. I am a believer!
    Crystal

  5. I have a very positive sotry to tell about Strontium! My 94 year old mother and I have taken Strontium citrate for 3 1/2 years now. I had tried all the natural usual things like calcium, magnesium, vitamin D, etc. I had been seeing specialists regarding my severe bone density problems for 20 years. Finally, with no help from these, my M.D. told me I needed biphosphates. I tried them, but couldn’t tolerate them. I couldn’t see ruining one perfectly good system for another. I was into osetoeporosis at an early age (62). My mother was very osetoporotic. I discovered an article telling about Strontium, and both mom and I decided to give it a try. You must take calcium, but not at the same time as Strontium. My density has improved gradually and last Dexa showed I had normal bones now. I took 2 nasty falls and no fractures! I can now waterski again on one ski!! It had been 12 years since I had been able to do that! Mother took a fall but no fracture! She had carotid testing and all is well as well as her kidney function, etc. Her bone density in her spine is almost normal now as well. It has worked wonderfully for me and my strength, balance, etc. are ALL IMPROVED! This stuff really works!!! Doris

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