Skeleton Pirate
Artist: LindaB
WELCOME TO STRONTIUM FOR BONES BLOG
Have you experienced negative, and even dangerous, side effects from Fosamax (alendronate), Boniva (ibandronate), Actonel (risedronate), Reclast (zoledronic acid), Prolia (denosumab), Forteo (teriparatide), Tymlos (abaloparatide), or other drugs 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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Browse the posts and visit the link library of references.
Visitors to my blog can leave comments or ask questions and can remain anonymous, if they wish. Their comments are relayed to my g-mail inbox. Below each post, the number of comments for that post is cited and underlined because it is a link. By clicking on that link below any post, a window opens so that a visitor can leave a comment. Ideally, visitors leave comments on posts most relevant to their comments. All comments to my posts are moderated by me.
Browse the posts and visit the link library of references.
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.
Labels:
adverse cardiac events,
EMA,
Osseor,
Protelos,
Servier,
strontium ranelate
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Wandering Skeleton
Artist: Joel Hoekstra
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.
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.
For More Information about Strontium
- A Dose-response Study With Strontium Malonate
- A Review of the latest insights into the mechanism of action of strontium in bone
- Antifracture Efficacy Over 10 Years With Strontium Ranelate
- Combination of Micronutrients for Bone (COMB) Study: Bone Density after Micronutrient Intervention
- Effect of bone strontium on BMD measurements
- Effects of SrR on Calcium Metabolism
- Effects of strontium ions on growth and dissolution of hydroxyapatite and on bone mineral detection
- Influence of strontium on bone mineral density and bone mineral content measurements by dual X-ray absorptiometry
- Interpretation of BMD Scans in Patients Stopping Strontium
- Melatonin-micronutrients Osteopenia Treatment Study (MOTS)
- National Osteoporosis Foundation
- Osteoporosis And Bone Physiology
- P471 BENEFICIAL EFFECTS OF STRONTIUM RANELATE COMPARED TO ALENDRONATE ON TRABECULAR BONE SCORE IN POST MENOPAUSAL OSTEOPOROTIC WOMEN: A 2-YEAR STUDY
- Post-Marketing Assessment of the Safety of Strontium Ranelate
- PubMed Abstract On The SOTI Study
- PubMed Abstract On The TROPOS Study
- Strontium ranelate Aristo
- Strontium Ranelate For Spinal Osteoarthritis
- Strontium: Breakthrough Against Osteoporosis
- Summary Safety Review - Strontium
- Thirteen Key Diagnostic Tests
9 comments:
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
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
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
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.
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
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/
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
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
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.
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