Strontium Warning

DO NOT TAKE STRONTIUM 680 mg. UNLESS UNDER MEDICAL CARE

Strontium Renelate (SR) is a drug developed in Europe for fracture prevention from Osteoporosis. Early 3 year results were very positive and while side effects were exactly the same as seen with those from osteoporosis drugs, Strontium group exhibited far lower adverse reactions than drugs. The amazing bone density building factors from SR yielded a 41% reduction in bone fracture rate the first year in one study.

Based on these results, vitamin companies came out with products containing similar strontium dosages but changed the combining element to get around the patent for Strontium being combined with Renelate. During digestion, strontium separates from the combining element, so the results of the drug study would apply to nutritional strontium combinations as well. Actually, there are some differences from animal studies showing some supplement forms of strontium actually exhibit higher absorption amounts than the drug form SR. The Drug company had to use a form of strontium that is not natural by combining it with synthetic Renelate so they could patent the product. MD blog on Strontium.

Now, after longer term SR use, some adverse effects are starting to surface for increased cardiac events. ref  This has prompted the European Medicines Agency in charge of patient safety to issue the following warning about the use of the Osteoporosis drug Strontium Renelate. ref

(Updated April 26, 2013) The European Medicines Agency has confirmed the recommendation to restrict the use of strontium ranelate (Protelos/Osseor, Servier) because of concerns about the risk for adverse cardiac events with the product. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended the restrictions earlier this month, and the Committee for Medicinal Products for Human Use (CHMP) has now endorsed this.

Strontium ranelate has been approved in Europe since 2004 for the treatment of osteoporosis to reduce the risk for vertebral and hip fractures in postmenopausal women. In 2012 the indication was expanded to include men at increased risk for fracture. It is not currently approved in the United States.

In a routine benefit/risk assessment of trials involving about 7500 patients, the PRAC found an increased risk for adverse cardiac events, including myocardial infarction (MI), in women receiving strontium ranelate compared with those who received placebo. However, there was no increased risk for death. There was also an imbalance in the number of serious cardiac events seen with the medicine in 2 other studies, one in men with osteoporosis and the other in patients with osteoarthritis, the CHMP said. 

This more in-depth risk evaluation was undertaken due to earlier concerns about other serious adverse events such as venous thromboembolism and rare but serious skin reactions with strontium ranelate.

The following restrictions apply, the CHMP said today:

• Strontium ranelate should only be used for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture and severe osteoporosis in men at increased risk for fracture.

• Strontium ranelate should not be used in patients with current or past history of ischemic heart disease (such as angina or MI), peripheral arterial disease, or cerebrovascular disease or in patients with uncontrolled hypertension.

• Physicians should base their decision to prescribe Protelos/Osseor on an assessment of the individual patient's risks. The patient's risk of developing cardiovascular disease should be evaluated before and at regular intervals during treatment.

The CHMP opinion will be sent to the European Commission, the executive branch of the European Union, which will issue a legally binding decision,

Analysis: While these adverse events are still in an early stage and research is needed to quantify the risk, the pattern developing is not a welcomed omen. It is Strontium acting like Calcium and not the ranelate part of SR that most likely is related to these effects. The ranelate is just the carrier for patent purposes. Thus, the over the counter nutritional supplement forms such as strontium citrate would most likely have the same effects, but they have not been tested in humans yet. In animal studies, they did exhibit the same type of effects that caused the events that initiated this warning. Strontium replaces calcium not only in bones changing their structure, but also in arteries if the calcium plaque building process is occurring. Calcium replaced by strontium in other soft tissues would be problematic since strontium is double the atomic weight of the calcium it is replacing. This could shorten the time to develop diseases related to this calcification or "strontification" of artery or kidney tissues. Precaution is the order of the day. 

Perhaps the proper protocol under Medical care to monitor would be the use of 680 mg Strontium or slightly less for a limited time or to a measured level of strontium effects and then back off and maintain benefits gained without entering too far into the newly discovered increased cardiovascular risk condition. Medical measurements would need to access body conditions to limit calcification changing into strondificaton in artery walls, but still adding a strength layer to bones. SR also helps limit bone tearing down cell activity. Obviously, vitamin companies hope it is the strontium by itself and not combination with renalic acid that does this particular action. 

A Different Strontium View for Supplements?

Here is a website that sells strontium products and has a different view about the supplement forms of strontium being safer than the drug form used in Europe, Strontium Renelate (SR). They claim using citrate instead as a combining agent with strontium would lower pH values in the body. These values are high in the typical American diet. Thus, this lower pH might mitigate some of the side effects observed from the renelate drug form of strontium. Quite a few assumptions without getting to the real point. It is the strontium displacing calcium in bones or artery walls that is at the root of the problem, not the combining element.

Here is the second study the above website cites in their references for the safety of using the citrate form of strontium. ref  It involves children, rickets, and natural strontium in soils getting into plant cereals and thus into the children's diet. But one part of the RESULT does not appear to be positive for Strontium. It says higher amounts of natural strontium in the diet increased rickets. Now, after reading the study abstract and discussion, is natural strontium as safe as the above website suggests, or otherwise...?

Yes, including adequate calcium makes strontium somewhat safer since calcium hinders strontium absorption, so a little less would be absorbed and participate in displacing calcium. Supplemental Calcium was also part of the SR drug studies that showed the positive outcome of consuming such high amounts of SR in reducing fracture risk.  But, now since higher amounts of natural strontium also will lead to problems in bone growth indicated by the rickets research, it is time to re-evaluate the use of such high amounts of strontium for bone health. After ten years of continuing to evaluate SR studies, an increased risk for heart attacks has surfaced. The length of time consuming could change the early benefits into long term detriments. Your Doctor would determine if short term benefits outweigh any long term adverse effects. 

CAUTION:  If you are consuming Strontium over 300 mg, in any form, it should be under the supervision of your medical Doctor. In the U.S. today, vitamin companies are not only selling over the counter Strontium supplements with the same high dosage as the drug SR, for one company this supplement is that company's number 1 selling product. Customers are completely in the dark about the possible adverse increase in cardiovascular events over time. Dr. Oz some time ago recommended this ingredient on his show for bone health, possibly without mentioning the few side effects and before the current long term adverse cardiovascular effects surfaced.

NOTE: Dec 2016, Supplement strontium availability is currently arriving at that 10 year window.