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Senior Citizen Health & Medicine
New Strontium Drug Reduces Fracture Risk in Older
Women with Osteoporosis
July 24, 2006 - Postmenopausal women with
osteoporosis may significantly reduce their risk of painful and
debilitating spine fractures by taking a prescription form of the
mineral strontium, a recent review of clinical trials has found.
The same formulation also may decrease the risk of
non-spine fractures, although the benefit seems smaller.
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Health & Medicine |
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“Strontium ranelate represents a new anti-osteoporotic
treatment for postmenopausal osteoporosis,” said lead author Siobhan
O’Donnell, of the clinical epidemiology program at the Ottawa Health
Research Institute in Canada. “The reduction in the relative risk of
vertebral fractures seems similar to the other approved therapies for
osteoporosis, although there are no head-to-head fracture trials
available.”
The review appears in the current issue of The
Cochrane Library, a publication of The Cochrane Collaboration, an
international organization that evaluates medical research. Systematic
reviews draw evidence-based conclusions about medical practice after
considering both the content and quality of existing medical trials on a
topic.
Strontium ranelate, sold under the brand name
Protelos by French pharmaceutical company Servier, is a bone-seeking
mineral similar to calcium. Its exact mechanism of action is unclear.
The drug was approved for use in the European Union in 2004 and is
currently available in 53 countries. So far, the United States is not on
that list.
The systematic review team pooled data from four
randomized controlled trials of strontium ranelate for osteoporosis
treatment or prevention. Three studies enrolled postmenopausal women
with osteoporosis, most of whom had already suffered at least one
osteoporosis-related fracture. The fourth study enrolled postmenopausal
women with osteopenia, low bone mass that does not meet the criteria for
osteoporosis but carries an increased risk of broken bones.
In the two treatment trials that evaluated the risk
of spine fractures, women who took 2 grams of strontium ranelate daily
had a 37 percent reduction in spine fracture risk over a three-year
period compared to women who received a placebo. For
osteoporosis-related fractures in other bones, these two trials showed a
14 percent reduction in risk at the same dose of strontium ranelate
compared to placebo.
There were not enough data to determine whether
strontium ranelate reduces the risk of hip fractures, which are among
the most costly and debilitating osteoporosis-related fractures.
“The real objective of therapy is to reduce
fractures, and it seems quite clear that strontium ranelate does have an
effect on this endpoint,” said Michael McClung, M.D., director of the
Oregon Osteoporosis Center. “For vertebral fractures, it’s in the same
ballpark as we see with virtually every other drug that’s been studied.”
However, according to McClung, the nonvertebral
fracture risk reduction of about 14 percent doesn’t compare very
favorably with the 40 percent to 50 percent reduction in risk seen with
the most commonly prescribed drugs for osteoporosis, Fosamax
(alendronate) and Actonel (risedronate). What’s more, said McClung,
“these are the only two drugs that have shown a reduction in hip
fracture risk in predesigned studies of people with osteoporosis.”
Osteoporosis-related fractures take a huge toll on
individuals, families, and society as a whole. An estimated 1.5 million
osteoporotic fractures occur every year in the United States, at a price
tag of $12 billion to $18 billion in direct medical costs. Hip fractures
account for about 300,000 hospitalizations every year and frequently
lead to disability.
While low bone mineral density is not the only risk
factor for fractures, it is a major one. For each incremental decrease
in bone mineral density, the risk of fracture increases by about 1.5 to
2.5 times.
In all four trials, strontium ranelate increased
bone density in both the spine and hip over a two- to three-year period.
While even the lowest dose tested yielded some improvement in bone
density compared to placebo, the greatest benefit was seen at the
highest doses tested — 2 grams in the treatment population and 1 gram in
the prevention population.
The most common side effect with the drug was
diarrhea. However, there were no differences in withdrawals from the
trials due to side effects.
“Based on the results of our systematic review,
strontium ranelate appears to be a well-tolerated therapy,” said
O’Donnell.
The reviewers found that strontium ranelate carried
a small absolute increase in the risk of potentially serious vascular
problems such as blood clots in the legs and lungs, although there was
no significant difference in deaths in the three trials that looked at
this outcome.
Two other drugs for osteoporosis, raloxifene (Evista)
and estrogen, also pose a minimal risk of these problems.
“The risks are small,” said McClung, “but what it
means for any of these drugs is that we shouldn’t be giving medicines
that have even modest risk to people where the benefit is going to be
very small.”
While strontium ranelate is not available in the
United States, supplements containing different forms of strontium are
available in health food stores. According to McClung, since these
supplements haven’t been subjected to rigorous trials, their
effectiveness is unknown.
“While it is possible that any strontium
preparation would be effective in improving bone strength and fracture
risk, that is an assumption,” said McClung. “For those of us who would
prefer to base our medical decisions on evidence, assuming that a
different strontium salt would be as effective as strontium ranelate is
disquieting.”
The review discloses that Jean-Yves Reginster, a
review co-author, was also an author on all four included trials.
O’Donnell S, et al. Strontium ranelate for
preventing and treating postmenopausal osteoporosis (Review). The
Cochrane Database of Systematic Reviews 2006, Issue 3.
The Cochrane Collaboration is an international
nonprofit, independent organization that produces and disseminates
systematic reviews of health care interventions and promotes the search
for evidence in the form of clinical trials and other studies of
interventions. Visit
http://www.cochrane.org for more information.
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