Skeleton Pirate

Skeleton Pirate
Artist: LindaB

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Have you experienced, or read about, negative, and even dangerous, side effects from Fosamax (alendronate), Boniva (ibandronate), Actonel (risedronate), and other bisphosphonates prescribed for osteoporosis? If you have, then rest assured there is a safe, effective treatment for this condition. Strontium, primarily in the form of strontium citrate, is taken orally once a day.

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Monday, April 29, 2013

EMA Confirms Recommendations to Restrict Strontium Ranelate

The European Medicines Agency (EMA) has confirmed the recommendations to restrict the use of strontium ranelate (Protelos/Osseor, Servier) due to concerns about the risk of adverse cardiac events. 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 these following its meeting of April 22-25, 2013. The CHMP opinion will be sent to the European Commission, the executive branch of the European Union, which will issue a legally binding decision.
 

9 comments:

Kathy said...

Hi Bone Lady,

Thank you again.

I'm disappointed the EMA hasn't given us the details which caused them to make this recommendation. There's always some risk, but this is so dictatorial. Are thinking people just supposed to blindly follow, like in the middle ages! Of course if it's a prescription matter, it's up to the prescribing physician. Are they deliberately trying to keep us in the dark!

Sorry to vent...what else can I do!

Kathy

BoneLady said...

Kathy,

"The EMA’s recommendations are based on an analysis of pooled data from randomized studies in about 7,500 post-menopausal women with osteoporosis. The results showed an increase in the risk of heart attack with Protelos/Osseor as compared with placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% confidence interval, 1.07 to 2.38). There was also an imbalance in the number of serious heart events seen with the medicine in two other studies, one in men with osteoporosis and another in patients with osteoarthritis. No increased risk in mortality was observed."


http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/04/news_detail_001774.jsp&mid=WC0b01ac058004d5c1

Kathy said...

Thank you Bone Lady,

I've struggled to understand what they are saying. I don't understand about the 'confidence interval' but it seems to say that 0.6% additional heart attack events occur with the strontium group. But there's no additional deaths in the Sr group. That doesn't sound like very much at all. Am I missing something?

Are you aware of any metabolic changes associated with long term Sr use? I mean: specifically weight gain. I've put on an additional 10 lbs in the year or so I've been taking the citrate form. That's not good and I'm trying to shift it but just wondering....

I really appreciate your opinions. At my age, it's a struggle to keep up.

Kath

BoneLady said...

Kathy,

The results showed a relative risk of 1.6 for heart attacks for the group on Protelos/Osseor compared to placebo. That result means someone taking strontium ranelate has a 60 percent higher risk of heart attacks than someone not taking the drug. That is quite significant.

However, we do not know if the risks are comparable for those of us taking strontium citrate. We do not know if the increased risks of cardiac events for strontium ranelate are due to strontium, ranelic acid, aspartame, or other artificial sweeteners.

I have read statements from people claiming to have had weight gain and/or bloating from strontium ranelate and/or strontium citrate, but I have not read clinical studies documenting these claims. Some of these people later admit to having changed their diets or to exercising less or to having recently been diagnosed with diabetes or hypothyroidism. The only way to know if your weight gain is from strontium citrate is to stop taking it and see if you lose the weight. You can reintroduce the strontium citrate at a later date if it is not the problem. Strontium citrate can cause constipation, which can cause bloating. Whether or not it can also cause weight gain, I do not know for sure.

Kathy said...

Thank you Bone Lady. That's very informative and I appreciate it. I'm gonna stop taking the citrate for a while.

One might think it would be financially beneficial for the Sr ranelate manufacturer to do some studies to pin-down what's causing those heart attacks.

I live in hopes!

Kath

BoneLady said...

Kathy,

Let me know how things go for you after you are off strontium citrate for awhile. Good luck losing the added pounds.

Also, I'd like to mention that studies that have been done on strontium citrate have not shown the negative side effects associated with strontium ranelate. The COMB study is one of the most recent clinical trials of strontium citrate. I ran a post about it. Here is a link to the journal article:
http://www.hindawi.com/journals/jeph/2012/354151/

Kathy said...

Hi Bone Lady,

I'll go read that article...thank you! I'll keep in touch.

All the years of my mother's problems with severe osteoporosis, I met one road-block after another. It was very traumatic. You are the only knowledgeable person I've met who reached out to help people and I won't soon forget you!

Kath

Anonymous said...

I have been reading with interest your blog and all the info on Strontium. With this EMA recommendation will it make you personally reconsider taking strontium citrate? Thank you for all you post. It has been vital in my trying to determine which treatment to take.

Colleen

BoneLady said...

Colleen,

No, the EMA recommendations have not made me reconsider taking strontium citrate. I have been taking it for five and a half years and continue to do so. I have had no problems, other than constipation, attributable to strontium citrate during all these years.

I do NOT have a current or past history of ischemic heart disease, PAD, cerebrovascular disease, or uncontrolled hypertension. I do have a history of high cholesterol and high triglycerides, but these are under control with medication. My blood pressure is normal at home but goes up at the doctor's office. This condition is termed white coat hypertension and does not require treatment unless it progresses to classic hypertension.

I have a family history of hypercholesterolemia and heart disease. My mother died of a massive myocardial infarction, as did her mother before her. Both lived normal life spans.

Of all the possible negative side effects of strontium ranelate, these latest ones are, to me, the most worrisome. If I were to develop ischemic heart disease, PAD, cerebrovascular disease, or uncontrolled hypertension, I might reconsider strontium citrate. I have no idea what I would take in its place because all the osteoporosis medications come with a litany of serious side effects.

Wandering Skeleton

Wandering Skeleton
Artist: Joel Hoekstra

Osteoporotic Bone

Osteoporotic Bone
Source: www.mayoclinic.com

How Strontium Builds Bones

Strontium is a mineral that tends to accumulate in bone. Studies have shown that oral doses of strontium are a safe and effective way to prevent and reverse osteoporosis. Doses of 680 mg per day appear to be optimal. See my "For More Information About Strontium" links section.

Osteoporosis is caused by changes in bone production. In healthy young bones there is a constant cycle of new bone growth and bone removal. With age, more bone is removed and less new bone is produced. The bones become less dense and thus more fragile.

Scientists believe that strontium works in two ways. It may stimulate the replication of pre-osteoblasts, leading to an increase in osteoblasts (cells that build bone). Strontium also directly inhibits the activity of osteoclasts (cells that break down bone). The result is stronger bones.

When taking strontium, be sure to take 1200 mg calcium, 1000 IU vitamin D3, and 500 mg magnesium daily. It is best to take strontium late at night on an empty stomach. Calcium and strontium may compete with each other for absorption if taken together.