Strontium Citrate Clinical Trial Results By Year End

Data from the three-month strontium citrate clinical trial known as the Scope Study are currently (as of November 4, 2010) being evaluated at the UC Davis Medical Center. Some results should be available by the end of the year. Stay tuned for the latest word from the Scope Team.

Strontium Ranelate Available In Mexico As Protos

I had been asked if strontium ranelate is available in Mexico. I knew the drug was available in different countries (not the U.S.) under various brand names. A spokesperson from Servier International just replied to my question: "Is Protelos available in Mexico? If it is available, what brand name is it sold under?" Here is the reply:

"Thank you for your interest for strontium ranelate/Protelos. In response to your question below, please be advised that strontium ranelate is available in Mexico under the brand name of Protos, however, please note that strontium ranelate has not been submitted to the FDA and, thus, is not approved for use in the USA."
Sincerely, M. Rebuffe-Scrive
Servier International

The Osteoporosis Patient With Renal Insufficiency

A German paper by G. Lehmann, G. Hein, and G. Wolf addresses the osteoporosis patient with renal insufficiency and what has to be taken into account in the selection and administration of medications for osteoporosis. Because the incidence of osteoporosis and renal insufficiency increases with age, the use of antiosteoporotic drugs approved for long-term administration in patients with inadequate renal function is a cause for concern. In the dose approved for the treatment of osteoporosis, oral bisphosphonates and i.v. ibandronate (3 mg every 12 weeks) are considered safe in patients with glomerular filtration rate (GFR) > 30 ml/min. Treatment with strontium ranelate and the osteoanabolic substance teriparatide is not altered by impaired renal function until GFR falls below 30 ml/min. Efficiency of the selective estrogen receptor modulator (SERM) raloxifene is not altered by renal function.
http://www.ncbi.nlm.nih.gov/pubmed/16924452

Picking a Bone With Contemporary Osteoporosis Management

I recently came across an abstract of a research article critical of contemporary osteoporosis management and recommending strontium, calcium, vitamins D and K, and essential fatty acids. The article was published in Clin Nutr. Apr. 2007;26(2):193-207 and Epub. Oct. 13, 2006, by S.J. Genuis and G.K. Schwalfenberg of the University of Alberta, Alberta, Canada. Here is the abstract of the paper entitled, "Picking a Bone with Contemporary Osteoporosis Management: Nutrient Strategies to Enhance Skeletal Integrity."

"Epidemic rates of osteoporosis in the western world have yielded intense efforts to develop management approaches to combat this potentially devastating disorder; recent research has unveiled innovative strategies which hold considerable promise for prevention of skeletal compromise and amelioration of suboptimal bone health. According to many algorithms and practice directives, the contemporary assessment and management of osteoporosis focuses heavily on determination of fracture risk and pharmaceutical intervention for those patients deemed to be at high risk. While routine recommendations for calcium and vitamin D have been incorporated into most regimens, disproportionately little attention has been given to recent research elucidating improved bone health and diminution in fracture rates experienced by patients receiving specific nutrients. In mainstream medical practice, clinical analysis and management of nutritional or dietary issues is sometimes perceived as unconventional, primitive or unsophisticated health care. Recent evidence-based research, however, supports intervention with adequate amounts of specific nutrients, including vitamin D, strontium, vitamin K, and essential fatty acids, in the prevention and primary management of osteoporosis."

http://www.ncbi.nlm.nih.gov/pubmed/17046114

Development Plan for Strontium Malonate in U.S.

On August 16, 2010, Osteologix, Inc., filed its quarterly Q-10, a required financial statement. Part of the report is quoted here: "We believe that our available existing resources will provide liquidity to fund our planned operations, excluding any clinical trials, into the second quarter of 2011. Because the business of developing pharmaceutical products is time-consuming and expensive, and NB S101 (strontium malonate), our most advanced investigational drug, still must complete pivotal human clinical trials before it can be marketed, we will require additional financial resources to carry out our business strategy. The development plan for NB S101 will require a larger phase 2 and/or phase 3 clinical trial that we estimate will take at least two years to complete. After or possibly concurrent with our next clinical trial, either one or two similar or potentially larger phase 3 trials will be required. We are seeking a third party development partner with substantially more resources than us for further clinical development in the United States, and we do not expect to proceed with further U.S. clinical development until we enter into a development agreement with such a partner Off-Balance Sheet Arrangements."

Strontium Malonate Licensing Agreement

On August 2, 2010, Osteologix and Servier announced an ex-U.S. licensing agreement for NB S101 (strontium malonate). Osteologix has granted Servier an exclusive royalty-bearing license to develop and commercialize NB S101 to treat postmenopausal osteoporosis, other bone and joint disorders and dental indications worldwide, except in the United States. Under the terms of the agreement, Osteologix will receive up to €12 million in upfront and milestone payments. Additionally, Osteologix is eligible to receive up to €30 million in minimum royalty payments creditable against mid to low single digit royalties on sales. Osteologix will also be eligible to receive milestone payments and royalties on product development and sales in Japan. Servier will be responsible for all costs outside of the U.S. associated with development, regulatory approval and commercialization of NB S101. Osteologix will continue to own intellectual property rights for development in the U.S. This information is from a press release issued by Osteologix at http://www.osteologix.com/wb0005.php?oid=12.

Another Strontium Citrate Success

Most of my posts are about my own experience with strontium citrate and about research on the various strontium salts. This post is about Sara S. DeHart's strontium success story, which she wrote about herself in two articles, the most recent one published online just a few days ago. In 2006, she was taking Actonel and developed a fracture at T-9. Later, that same year, she switched to strontium citrate (750 mg strontium/day) and has had no further vertebral fractures. Here are her T-scores from 2006 to the present:

Left Hip Lumbar Spine

2006 -1.2 -1.4
2008 -0.6 -0.2
2010 -0.5 +0.2

Here is the original article: http://onlinejournal.com/artman/publish/printer_6185.shtml

My Daily Supplements

One of my readers asked me to add more information about supplements. I’ve decided to list all the ones I currently take. This list may provide a start for your own research. Each person’s needs will vary depending on age, sex, diet, and health.

Doctor’s Best Strontium Bone Maker, 2194 mg strontium citrate, 680 mg elemental strontium in two capsules
Nature Made Multi For Her 50+ (contains 22 key nutrients, including 1000 IU vitamin D3, 200 mg calcium, 100 mg magnesium, 80 mcg vitamin K, 2500 IU vitamin A with 60% as beta carotene, 25 mcg vitamin B12, 180 mg vitamin C, 60 IU vitamin E, 15 mg zinc, 70 mcg selenium)
Nature Made Vitamin C, 500 mg
Nature Made Vitamin E, 100 % Natural, 400 IU
Kal Extra-Strength Calcium Magnesium (I take one tablet, which contains 500 mg calcium and 250 mg magnesium.)
Kal Bioflavonoids 1000
Finest Natural Zinc, 50 mg
Finest Natural Selenium, 200 mcg
Nature’s Bounty Lutein, 20 mg
Nature’s Bounty Sublingual Vitamin B12, 2500 mcg (I take one tablet Monday, Wednesday, and Friday.)
Bluebonnet Lecithin, 1365 mg (I take three capsules daily.)
Nature’s Way Primadophilus bifidus

Also look up my previous posts:
03/30/2010 “How Much Calcium Are You Getting?” (Includes IOF’s Calcium Calculator)
03/29/2010 “Strontium With Insufficient Calcium and Magnesium, A Case Study”
03/22/2010 “Strontium And Calcium”

Preniva For Osteoporosis

Recently, Saturday Night Live (SNL) did a skit about Preniva, a drug women don't need for osteoporosis but are scared into taking for our weak bones. Many of you have seen the Sally Field commercials for Boniva and will recognize the pun. Health Freedom Alliance posted the video with an introduction by Drew Kaplan. The Alliance, SNL, and I want people to be wary of tactics used by the big pharmaceutical companies to scare us into taking their sometimes useless and dangerous drugs. They often use celebrities, who may or may not take the drugs themselves, to make us believe they take them and love them. They imply that not taking their drugs could have dire consequences for our health. Follow this link for a real treat:

http://healthfreedoms.org/2010/05/24/snl-gets-it-right/

Proton Pump Inhibitors May Increase Fracture Risk

On May 25, 2010, the U.S. Food and Drug Administration (FDA) announced that it would add safety information about the possible increased risk for hip, wrist, and spine fractures to the prescription and over-the-counter (OTC) labels for Proton Pump Inhibitors (PPIs), which include esomeprazole (Nexium), omeprazole (Prilosec, Zegerid), and lansoprazole (Prevacid).

PPIs treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Ironically, PPIs are commonly prescribed to treat side effects, such as dyspepsia or heartburn, commonly associated with bisphosphonates.

Dr. Amar R. Deshpande, an assistant professor of gastroenterology at the University of Miami Miller School of Medicine, said PPIs may disrupt the body's ability to absorb calcium, which, in turn, can increase the risk for fractures. He also believes this class of drugs is overused and often taken for too long.

The FDA is advising consumers to not stop taking PPIs until they have consulted with their doctors. However, patients should be aware of the increased risk for fractures. The highest risk was seen in people taking higher doses of PPIs, or among those who took them for a year or more. For people taking OTC proton pump inhibitors, the FDA said they should only be taken for 14 days to help ease frequent heartburn. If heartburn continues, people should see their doctor. Under no circumstances should over-the-counter PPIs be taken for more than three 14-day periods in a year, the agency said.

Strontium Ranelate Reduces Fracture Risk In The Elderly

According to a study by Ego Seeman et al., strontium ranelate produces an early and sustained reduction of both vertebral and nonvertebral fractures in women 80 years of age and older. More than 30% of all fragility fractures and 60% of hip fractures occur in women aged 80 and older, because of the high prevalence of osteoporosis and high incidence of falls. The aim of this study was to determine whether strontium ranelate, an agent that reduces the risk of vertebral and nonvertebral fractures in postmenopausal women >50 years of age, also reduces fractures in the elderly.

An analysis based on pooled data from two international, phase III, randomized, placebo-controlled, double-blind studies (the Spinal Osteoporosis Therapeutic Intervention [SOTI] and TReatment Of Peripheral OSteoporosis [TROPOS]) included 1488 women between 80 and 100 years of age followed for three years. Yearly spinal X-rays were performed in 895 patients. Only radiographically confirmed nonvertebral fractures were included.

The risk of vertebral, nonvertebral, and clinical (symptomatic vertebral and nonvertebral) fractures was reduced within one year by 59% (p = 0.002), 41% (p = 0.027), and 37% (p = 0.012), respectively. At the end of three years, vertebral, nonvertebral, and clinical fracture risks were reduced by 32% (p = 0.013), 31% (p =0.011), and 22% (p = 0.040), respectively. The medication was well tolerated, and the safety profile was similar to that in younger patients.

The authors concluded that treatment with strontium ranelate safely reduces the risk of vertebral and nonvertebral fractures in women with osteoporosis aged 80 and older. Even in the oldest old, it is not too late to reduce fracture risk.

J Bone Miner Res 2006;21:1113–1120. Published online on May 8, 2006; doi: 10.1359/JBMR.060404

How Much Calcium Are You Getting?

To determine how much calcium to supplement, first figure out how much calcium you are already getting. The International Osteoporosis Foundation (IOF) has a calcium calculator to find out if you are getting enough calcium in your diet each day. Remember, women ages 19 to 50 need at least 1,000 mg of calcium daily. Women over 50 need at least 1,200 mg. Here is the link to the calculator:

http://www.iofbonehealth.org/patients-public/calcium-calculator.html

Strontium With Insufficient Calcium and Magnesium , A Case Study

In 2008, Sara S. DeHart, MSN, Ph.D, published "Strontium and Osteoporosis: A Treatment Not Offered to American Women." The article presents her own case study of how she was treated for osteopenia by traditional medicine while continuing to fracture until she learned to treat herself with strontium citrate. I want to emphasize what she wrote about the importance of taking adequate levels of calcium and magnesium, along with the optimum levels of strontium citrate, and what happened to her before she realized this relationship.

"By that time (2006), I’d been investigating alternative therapies and added Strontium Bone Maker (1000 mg strontium citrate, 340 mg elemental strontium per day). I later increased the dosage to 2000 mg daily (680 mg elemental strontium), which is the dosage used in the strontium ranelate clinical trials (Meunier, Roux, Seeman, et al. 2004). The larger dosage led to a drop in my serum calcium level that was sufficient to cause muscle tetany in both hands. (Note I discontinued Actonel in 2007 and the muscle pain decreased significantly.) The larger dosage of strontium with insufficient calcium and magnesium caused the serum calcium level to drop. I increased my calcium + magnesium dosage and the serum calcium and ionized calcium levels returned to normal."

"Currently I am taking Osteo-MINS AM from the Tahoma Clinic in Renton, Washington, (700 mg per 3 capsules), though I have also used Strontium Support (AOR) from a Canadian firm. The Osteo-MINS AM appears to be the better formulation for my highly sensitive muscles. I take strontium two hours before breakfast so that it has cleared my digestive track prior to taking food or any calcium/magnesium. This is an important part of my supplementation program because without it my serum calcium level will drop and that has an effect on muscles throughout the body."

To read the entire article, see http://www.intrepidreport.com/archives/2608

Strontium And Calcium

For patients taking any strontium salt (e.g., strontium ranelate, strontium citrate) for osteoporosis, it is recommended that you obtain an adequate calcium intake as part of a well balanced diet. If you have difficulties obtaining adequate calcium from your diet, a calcium supplement may also be required. (All patients participating in the strontium ranelate research trials had an adequate calcium intake.) Take your calcium supplement or calcium-rich food at least two hours before or two hours after you have taken the strontium because calcium will prevent the absorption of strontium.

There is an upper limit to the amount of calcium that can be taken safely. It is recommended that you do not exceed 2000 - 2500 mg of calcium per day included in your food, drink and supplements. Consistently exceeding the upper limit may increase your risk of medical problems, including a high level of calcium in the blood (milk alkali syndrome), and may interfere with the absorption of other minerals such as iron. If you have a history of kidney stones, consuming a diet rich in calcium will not increase your risk of further stone formation. Most renal doctors do not restrict calcium intake for their patients these days.

Splitting your calcium intake into 500-mg doses is advisable, as the gut would not be able to absorb 1000 mg all at once. To maximize the absorption of your calcium tablet, take it at meal times with or after food. If you take iron tablets for other health reasons, avoid taking calcium at the same time by staggering the tablets throughout the day. This will ensure that both minerals are fully absorbed.

This information is from the National Osteoporosis Society, located in the United Kingdom, where strontium ranelate (Protelos) is an approved prescription drug for the treatment of postmenopausal osteoporosis. To obtain NOS publications and Information Sheets, go to www.nos.org.uk.

FDA Safety Announcement About Bisphosphonates

Most readers who visit my blog have either already stopped taking bisphosphonates for osteoporosis or are seriously contemplating doing so and switching to strontium or something else. ABC News has recently reported on femur fractures occurring in some patients following several years on bisphosphonates. In response to those news reports and the outcry from viewers, on 03/10/2010, the FDA issued a Drug Safety Communication on bisphosphonates and femur fractures. Here is part of that announcement:

"Patients and healthcare professionals may have questions about oral bisphosphonate medications and atypical subtrochanteric femur fractures – fractures in the bone just below the hip joint. Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis in postmenopausal women. Common brand names of medications in this class include Fosamax, Actonel, Boniva, and Reclast."

"Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these medications. At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue." See the entire FDA announcement at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

Report any adverse events with the use of oral bisphosphonates to FDA's MedWatch program:

1-800-332-1088
1-800-FDA-0178 Fax
MedWatch Online2
Regular Mail: Use postage-paid FDA Form 35003
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787

Strontium Ranelate Reduces Vertebral Fracture Risk

The primary goal of any osteoporosis treatment is prevention of stress fractures. The following abstract is from one of the most recent studies on strontium ranelate highlighted by the International Osteoporosis Foundation (IOF) at www.iofbonehealth.org/pio/latest-issue/volume-10-issue-4-2009/overview.html:

"Meunier et al report on 1649 osteoporotic women randomized to strontium ranelate (SrR) or placebo for four years followed by a one-year treatment-switch period for half of the patients. Over four years, risk of vertebral fracture was reduced by 33%. Among patients with two or more prevalent vertebral fractures, risk reduction was 36%. Lumbar BMD increased over five years in patients who continued with SrR, and decreased in patients who switched to placebo. Osteoporos Int 2009;20:1663-73"

Strontium Citrate Clinical Trial Still Recruiting

"The researchers are seeking post-menopausal women who are at least one year but less than five years past their last menstrual period. Participation in the study will include a screening visit with blood draw at UC Davis Medical Center, followed by a blood draw and free DEXA scan at the Veterans Administration Northern California Health Care Center."

"Participants will be randomly assigned to one of two groups. One group will take strontium citrate plus calcium and vitamin D for three months, while the other group will take a placebo plus calcium and vitamin D for three months. During the three-month period, participants will visit UC Davis Medical Center three times for short questionnaires and blood draws. DEXA scans and test results can be provided to participants.For more information or to schedule a screening visit, contact Stephanie Burns, study coordinator, at (530) 754-7576 or (916) 734-5562 or scope@phs.ucdavis.edu."

Update On Strontium Citrate Clinical Trial

Here is the latest update on the Strontium Citrate Clinical Trial known as the Scope Study and being conducted at the University of California at Davis (UCD). Per Stephanie Burns, study coordinator, "we are currently half-way through our recruitment period. We should have results in about a year’s time."