Health
Strontium and osteoporosis: A treatment not offered to American women
By Sara S. DeHart, MSN, Ph.D.
Online Journal Contributing Writer


Jul 7, 2008, 00:17

The purpose of this article is to provide a summary of current published research on the mineral strontium and its purported function in preventing osteoporotic fractures in postmenopausal women. This mineral is available through regular medical sources in Europe and is approved for use in 21 European countries. A case study of my own journey through this morass of data and treatment options is included for comparative purposes of what happens to postmenopausal women in the United States.

Most American women have never heard of Strontium and if they have heard of the mineral at all, it is Strontium-90, a radioactive isotope produced by nuclear fusion in the 1950s. As a result of above-ground nuclear testing radioactive strontium spread throughout the environment and contaminated dairy products and thereby accumulated in the bones of children and adults. Stable strontium is nontoxic, even when administered in large doses and may be one of the most effective substances yet found for the prevention and treatment of osteoporosis and other bone-related conditions. (Dean, 2004) [1]

Strontium gravitates to bone especially in parts where active remodeling is taking place. Dean (2004) and others report the study conducted in 1955 at the Mayo Clinic in Rochester, MN. This was a small study of 32 severely osteoporotic women who had suffered one or more vertebral fractures. They were administered 1.7 Grams of strontium lactate daily. Eighty-four percent of the patients reported marked relief of bone pain. No significant side effects were seen during the length of the study (3 years). Given the promising results of this initial work one would think that an American pharmaceutical company would have followed up with additional studies. Why didn�t this happen? The only reason is that the mineral strontium cannot be patented, so further research in the United States came to a halt.

It was not until Servier, a French pharmaceutical company patented a formula of strontium and ranelate under the drug name Protelos and began large scale testing that any systematic clinical trials were conducted. Strontium is only available in the United States as a mineral supplement and women are �on their own� if they choose this route. This treatment is not included in current �Standards of Care,� so American physicians will not venture outside those particular guidelines lest they be open to censure.

My own case study is interesting in that I followed all medical guidelines and ended up with severe osteoporosis and suffered two vertebral fractures. I am a 76-year-old Caucasian woman who completed menopause at age 53. I was physically active and walked at least two miles a day for 20+ years to and from the University of MN regardless of the weather. I also swam daily and practiced Hatha Yoga on a sporadic basis. My initial Dexascan at age 55 indicated that I had osteopenia with �high risk for fracture.� I reacted as most women do with that kind of diagnosis. I followed current medical recommendations. I was placed on Hormone Replacement Therapy (patch) and continued my exercise routine. Vitamin D levels were not tested but since I lived in Minnesota I presume that they were somewhat marginal. I used the RDA recommendation of 400 IU Vitamin D3 daily. This is clearly not sufficient since recent research indicates that at least 2000 IU Vitamin D3 must be used to be effective (Miller, 2007; Sardi, 2007). [2; 3]

My first real wake-up call came in 1998 with a fracture of the right wrist. Then in 1999 I fractured the left tibia. Both of these fractures were due to traumatic injuries and my physician from the Women�s Health Center told me �don�t worry, people break bones all the time.� She prescribed Fosamax and didn�t believe me when I said the drug caused severe muscle pain. I changed doctors and the new physician ordered Actonel, 5 mg daily, though he wanted me to use the weekly dosage (35 mg.). This dosage caused severe muscle pain, stiffness and contractions; hence the dosage was reduced to 5 mg 5 times per week.

I continued this level of Actonel until 2004 when I developed a spontaneous fracture at the sacral Iliac joint. In 2006, I developed a spontaneous osteoporotic vertebral fracture of T9. By that time I�d been investigating alternative therapies and added Strontium Bone Maker (1000 mg per day). I later increased the dosage to 2000 mg daily which is the dosage used in the Strontium Ranelate clinical trials (Meunier, Roux, Seeman, et al. 2004) [4]. 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.

T-Scores are used to grade Bone Density Mass (BDM) using the following scale:

Greater than (-1) = Normal BDM
Between (-1 and -2.5) = low BMD (osteopenia)
(-2.5 or lower) = Osteoporosis

So what happened to my Dexascans after I added the mineral strontium? This makes my T-score data meaningful as shown below.

Dexascan History Data

Left Hip: (2006) T-Score -1.2 -- (2008) -0.6

Lumbar: (2006) T-Score -1.4 -- (2008) +0.2

According to WHO standards my BDS data are now normal and I am no longer at increased fracture risk. Given that these Dexascan results have changed significantly with the addition of Strontium, it would seem appropriate to conduct clinical trials in the United States; this of course, is being done in Europe and Canada. Would my Dexascan results have been better or worse with the European patented formulation Strontium Ranelate cannot be answered without wide scale clinical trials. The European fracture prevention data on two large clinical trials (Spinal Osteoporosis therapeutic Intervention and Treatment of Postmenopausal Osteoporosis) are promising and American women need more options than the bisphosphonates (Fosamax, Actonel, Boniva), Hormone Replacement Therapies (HRT) or Forteo (synthetic Parathyroid Hormone) currently available.

Strontium. The major research literature is coming from Europe using the patented drug Strontium Ranelate. Blake and Fogelman (2006) [5] provided a review of the safety and efficacy of this formulation using two large multinational trials, the SOTI (Spinal Osteoporosis Therapeutic Intervention and TROPOS (Treatment of Postmenopausal Osteoporosis) studies. According to the data cited from the SOTI database, 1,649 postmenopausal women with a mean age of 69 years with at least one previous vertebral fracture and low spine bone mineral density (BMD) (equivalent to a Hologic spine T-score below -1.9). The strontium ranelate group had a 41 percent lower incidence of a new vertebral fracture than the placebo group over the three-year study period.

The TROPOS study evaluated non-vertebral fracture prevention in 5,091 postmenopausal women with a mean age of 77 years. The subjects were aged 74 years and over (or 70-74 with one additional risk factor) and a low femoral neck BMD (T-score below -2.2). Over the three-year study period there was a 16 percent reduction in all non-vertebral fractures and a 19 percent reduction at the principal sites for non-vertebral fractures.

The TOPOS study was not powered to investigate hip fracture risk. However in the high risk group of women aged 74 years and over with a femoral neck T-score of less than -2.4 there was a 36 percent reduction in hip fracture risk. Calcium and Vitamin D supplements were given to experimental and placebo groups in both the TOPOS and SOTI studies.

The investigators report that the overall incidence of adverse events did not differ significantly from placebo and were generally mild and transient, the most common being nausea and diarrhea. The authors did not discuss the very serious side effect of lowered serum calcium if insufficient calcium, magnesium and Vitamin D3 are not included in the protocol. Strontium has a chemical affinity for calcium; therefore these two minerals should not be taken in combined form. Dr. Jean-Yves Reginster, an investigator with the World Health Organization (WHO) whose work is cited in a paper published by Advanced Orthomolecular Research (AOR) a Canadian supplement firm provides this cautionary note: �The simultaneous intake of [strontium] and calcium remarkably reduces the bioavailability of [strontium]; therefore, high-dose strontium should not be taken concomitantly with a meal or calcium intake. (AOR, 2008 [6]; Reginster, Deroisy, & Jupsin, 2003 [7])

As noted earlier the majority of scientific data-based studies are reported from European and Canadian sources for the patented drug Strontium Ranelate manufactured by the French pharmaceutical company Servier and sold in Europe under the brand name Protelos. Protelos or Strontium ranelate and has been approved for use as an osteoporosis medication in 27 European Countries [8]. It has not been approved by the FDA for use in the United States, even though the strontium is available as a supplement through various sources (AOR; Tahoma Clinic Renton, WA).

Three papers are of special interest for their content on the supplement Strontium: Strontium for osteoporosis: To dose or to megadose (Gaby, 2006) [9]; Fight-even prevent-osteoporosis with the hidden secrets of this bone-building miracle mineral (Wright, 2008) [10]; Strontium: Breakthrough against osteoporosis (Dean, 2004) [11].

Dr. Wright�s paper includes a special caution about use of the injectable drug Forteo since it carries a black box warning from the FDA for osteosarcoma in laboratory rats. The drug is also prohibitively expensive ($600/month) and must be injected daily. Since it is a synthetic form of parathyroid hormone (PTH), there are additional concerns that the parathyroid glands may become inactive with continued use of the drug. Since the four small parathyroid glands, each about the size of a grain of rice, are responsible for calcium metabolism I am extremely leery of messing with them. Wright, along with others recommend taking 1,200-1,500 mg of calcium per day along with magnesium and other minerals and nutrients.

Dean [11] concludes his paper with this recommendation: Strontium in doses up to 1.7 grams per day appear to offer a safe, effective and inexpensive approach to preventing and reversing osteoporosis and may be of benefit in patients with osteoarthritis and cancer with bone metastases. Doses of 680 mg/day appear to be the optimum dose, although lower doses are clinically effective.

Dean along with Wright and Gaby believe that while most studies cited used only strontium, plus calcium and vitamin D-3, other anti-osteoporotic substances such as magnesium, vitamin K and boron are also important.

Why not just stick with Bisphosphonates (Fosamax, Actonel and Boniva) the drugs most prescribed by U.S. physicians?

There are several sources that discuss this issue in detail: The McDougall Newsletter (April 2008) [12] and Ott (2005) in an editorial in The Journal of Clinical Endocrinology and Metabolism titled Long term safety of bisphosphonates [13]. Dr. Ott concludes with this warning: The bisphosphonates in doses used today suppress bone formation to a greater extent than other antiresorbing medications, so it is possible that microdamage accumulation would develop after 15 or 20 years -- just about the time between menopause and the usual onset of osteoporotic fractures. Certainly this is an issue that requires long-term, carefully designed research.

I wonder if this is what happened to me, given the length of time I was on the bisphosphonates. It is certainly a tenable hypothesis.

A Cautionary Note: The importance of exercise and diet often appears as an after-note if it is mentioned at all. A pill or supplement will not turn the tide for the osteoporosis epidemic that afflicts postmenopausal women. Regular weight bearing exercise and nutritional support that uses a plant-based diet will eventually alter the equation for modern women. (See Dr. McDougall�s newsletters posted on the Internet to learn how to live well without animal protein, dairy or eggs.

References

1. Dean, W. (May 5 2004). Strontium: Breakthrough against osteoporosis.
   
   
2. Miller, D.W. (September 10, 2007). Vitamin D in a new light.
   
   
3. Sardi, B. (February 20 2007). Just one pill away.
   
   
4. Meunier, P.J., Roux, Seeman, E. et al. (2004). The effects of Strontium Ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. The New England Journal of Medicine, 350 (5) 459-468.
   
   
5. Blake, GM & Fogelman, I. (2006). Strontium ranelate: A novel treatment for postmenopausal osteoporosis: A review of safety and efficacy. Clin. Interv. Aging, I (4) 367-75.
   
   
6. AOR Newsletter: Osteoporosis Information.
   
   
7. Reginster, JY, Deroisy & Jupsin, I. Strontium ranelate: A new paradigm in the treatment of osteoporosis. Drugs Today (Barc). 203 Feb; 39 (2) : 89-101.
   
   
8. Servier website for Protelos or Strontium Ranelate (2008).
   
   
9. Gaby, Alan R. (2006). Strontium for osteoporosis: To dose or to megadose? The Townsend letter Group.
   
   
10. Wright, J.V. Fight-even prevent-osteoporosis with the hidden secrets of this bone-building miracle mineral. (Reprint from Nutrition and Healing, Tahoma Clinic, 2008).
    
    
11. Dean, W. (May 5 2004). Strontium: Breakthrough against osteoporosis.
    
    
12. McDougall, J. Patients commonly receive misinformation on osteoporosis treatments. The McDougall Newsletter (April 2008).
    
    
13. Ott, S.M. (2005). Long-term safety of bisphosphonates. The Journal of Clinical Endocrinology & Metabolism, 90 (3) (1897-1899).