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
- Dean,
W. (May 5 2004). Strontium:
Breakthrough against osteoporosis.
- Miller,
D.W. (September 10, 2007). Vitamin D in a new
light.
- Sardi,
B. (February 20 2007). Just one pill away.
- 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.
- 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.
- AOR
Newsletter: Osteoporosis
Information.
- Reginster,
JY, Deroisy & Jupsin, I. Strontium ranelate: A new paradigm in
the treatment of osteoporosis. Drugs
Today (Barc). 203 Feb; 39 (2) : 89-101.
- Servier
website for Protelos or Strontium Ranelate (2008).
- Gaby,
Alan R. (2006). Strontium for osteoporosis: To dose or to megadose? The Townsend letter Group.
- 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).
- Dean,
W. (May 5 2004). Strontium:
Breakthrough against osteoporosis.
- McDougall,
J. Patients
commonly receive misinformation on osteoporosis treatments. The McDougall Newsletter (April
2008).
- Ott,
S.M. (2005). Long-term safety of bisphosphonates. The Journal of Clinical Endocrinology
& Metabolism, 90 (3) (1897-1899).
Sara S. DeHart, MSN, Ph.D. is Associate
Professor Emeritus University of MN, School of Nursing. She also served as a
Visiting Scholar University of WA. She currently resides in the Northwest and
writes about various issues including public health and public policy. See
Substituting deception for sound public health policy. In Jerry �Politex� Barrett
(2004) "Big Bush Lies, "Riverwood Books (117-128). She may be
contacted at dehart.ss@verizon.net.