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.

 

Strontium and Your Heart

A committee of the European Medicines Agency (EMA) has recommended the following restrictions in the use of strontium ranelate (sold in the European Union under the brand names Protelos and Osseor) to reduce the risk of adverse cardiac events:

1a. 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.

2a.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 (PAD), or cerebrovascular disease.

3a.Strontium ranelate should not be used in patients with hypertension that is not controlled by treatment.

http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/human/000560/WC500142021.pdf

What, if anything, should those of us taking strontium citrate do?

Here is what I think.

1b. Strontium citrate can be used as a supplement by men and women with osteopenia or osteoporosis. (I believe the first restriction on strontium ranelate is mostly for cost containment because bisphosphonates, especially the generic equivalents, are much cheaper than strontium ranelate.) 

2b. Strontium citrate can be used UNDER MEDICAL SUPERVISION in patients with current or past history of ischemic heart disease, PAD, or cerebrovascular disease.

    3b. Strontium citrate should not be used in patients with uncontrolled hypertension. Patients must get their hypertension under control by medication. Strontium citrate can be used UNDER MEDICAL SUPERVISION in patients with hypertension that is controlled by treatment.

Vitamin D Supplements and USP Verification

Vitamin D supplement potency varies widely, and the amount of vitamin D in over-the-counter and compounded supplements does not necessarily match the amount listed on the label, according to a research letter published February 11, 2013, in the journal JAMA Internal Medicine.

The analysis showed that the amount of vitamin D in these supplements ranged from 9 percent to 146 percent of the amount listed on the label. Not only was there variation among different brands and manufacturers, but also among different pills from the same bottle. The researchers were surprised by the variation in potency among these vitamin D pills. The greatest concern is that individuals with low levels of vitamin D in their blood and consistently taking a supplement with little vitamin D in it, could face health consequences.

The U.S. Food and Drug Administration (FDA) is considering new safety guidelines for some supplements, but, for the most part, the industry remains unregulated. Some manufacturers participate in a voluntary quality verification program operated by the U.S. Pharmacopeial Convention (USP) — an independent, nonprofit organization that sets public standards for the quality of dietary supplements. In order to receive the USP verification mark, manufacturers' facilities undergo annual good manufacturing-practice audits, and their products are tested for quality, potency and purity. Dr. LeBlanc and her colleagues included one supplement from a USP Verified manufacturer in their sample. They found the amount of vitamin D in pills from that bottle was generally more accurate than the other bottles tested.

"The USP verification mark may give consumers some reassurance that the amount of vitamin D in those pills is close to the amount listed on the label," said Erin S. LeBlanc, MD, MPH, lead author and investigator with the Kaiser Permanente Center for Health Research in Portland, Oregon. "There are not many manufacturers that have the USP mark, but it may be worth the extra effort to look for it."

The researchers tested 55 bottles of over-the-counter vitamin D from 12 different manufacturers. The over-the-counter vitamin D pills used in the analysis were purchased at five different stores in Portland, Oregon. The compounded vitamin D was made by a compounding pharmacy in Portland. The analysis was conducted by Eagle Analytical Services, an independent lab in Houston.

http://www.heraldonline.com/2013/02/11/4611392/vitamin-d-potency-varies-widely.html

USP Verified Dietary Supplements

Click on the brand names below to see a list of USP Verified products and a list of the retail stores where you can buy the products.

Berkley & Jensen		Equaline		Kirkland Signature
Nature Made		Sunmark		Safeway
TruNature

http://www.usp.org/usp-verification-services/usp-verified-dietary-supplements/verified-supplements

Note: I use Nature Made Multi For Her 50+, a multivitamin that contains 1000 IU vitamin D3. There are also several Nature Made vitamin D supplements: Vitamin D—400 IU, Vitamin D3 1000 IU Softgels, Vitamin D3 2000 IU Softgels, and Vitamin D3 5000 IU Softgels. This brand is carried at several brick-and-mortar stores. I buy mine online at www.iherb.com. If you use my code, KAP600, at checkout, you and I both get a discount.

Hip Fracture Risk and Antihypertensive Drugs

Are you taking strontium citrate or one of the osteoporosis medications to increase your BMD and decrease your bone fracture risk? Here is something else to consider if you are at least 66 years of age. 
 
Initiating antihypertensive drugs in the elderly has been associated with an immediate increased risk of falls. The most likely mechanism is orthostatic hypotension, which is associated with dizziness and fainting. The effect is acute, occurs over a relatively short time, and may lead to falls, some of which can result in hip fractures.

The following study was undertaken to determine whether initiation of antihypertensive drugs (e.g., thiazide diuretics, angiotensin II converting–enzyme inhibitors, angiotensin II receptor blockers, calcium channel blockers, or β-adrenergic blockers) was associated with an immediate increased risk of hip fractures. Health care administrative databases were used to identify patients initiating an antihypertensive drug in Ontario, Canada. Elderly  people who began receiving an antihypertensive drug had a 43% increased risk of having a hip fracture during the first 45 days following treatment initiation.

http://archinte.jamanetwork.com/article.aspx?articleid=1392493

http://www.medscape.com/viewarticle/774769?src=mpnews

 

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Case Study on Strontium Citrate for Osteoporosis with Fragility Fractures

Sara S. DeHart, MSN, Ph.D., is an 80-year-old woman who was diagnosed with osteopenia at age 63. She was treated initially with Fosamax 10 mg. daily and Estraderm patches twice weekly.  She discontinued the patches after about two years, and Fosamax after about three years. Following a fragility fracture of the sacrum, she was prescribed Actonel 5 mg five times a week. Her vitamin D blood level was found to be very low, although she had supplemented with 400 IU vitamin D3 throughout her adult life.

She followed “standards of care” medical recommendations until she developed a second fragility fracture at T9 while taking Actonel.  At that point, she stopped using Actonel and began taking strontium citrate. She increased her vitamin D3 supplementation. Today, she is 80 years old and her BMD is normal. More importantly, she has not fractured, even after a recent fall onto an asphalt driveway! Follow this link to read her amazing story:

http://www.intrepidreport.com/archives/7529