By: Barbara Lagoni
A recent study raised
serious questions about the safety of osteoporosis drugs:
NEW CAUTIONS ABOUT LONG-TERM USE OF BONE DRUGS
By TARA PARKER-POPE | May 9, 2012
By TARA PARKER-POPE | May 9, 2012
An X-ray shows a
fracture in the femur of a woman who used Fosamax for seven years.
In an unusual move that
may prompt millions of women to rethink their use of popular bone-building
drugs, the Food and Drug Administration published an analysis that suggested
caution about long-term use of the drugs, but fell short of issuing specific
recommendations.
The F.D.A. review,
published in The New England Journal of Medicine online on Wednesday, was
prompted by a growing debate over how long women should continue using the
drugs, known as bisphosphonates, which are sold as generic versions of brands
like Fosamax and Boniva, as well as Novartis’s Reclast.
The concern is that
after years of use, the drugs may in rare cases actually lead to weaker bones
in certain women, contributing to “rare but serious adverse events,” including
unusual femur fractures, esophageal cancer and osteonecrosis of the jaw, a
painful and disfiguring crumbling of the jaw bone.
Although the concerns
about the long-term safety of bone drugs are not new, the F.D.A. performed its
own systematic review of the effectiveness of bisphosphonates after years of
use. The agency’s analysis, which found little if any benefit from the drugs
after three to five years of use, may prompt doctors around the country to
rethink how they prescribe them.
The F.D.A. review
analyzes only long-term use and does not address whether a woman should be
prescribed a bone drug in the first place to reduce her fracture risk. Because
serious complications are so rare, most doctors believe that for women with
documented osteoporosis who are at very high risk for spinal fractures, the
benefits of the drugs far outweigh the risks.
However, some women with
moderate bone density and no other risk factors continue to take the drugs for
years even though they are unlikely to gain any benefits. “I think a lot of
people are going to come off this drug,” said Dr. Clifford J. Rosen, an
endocrinologist and researcher at the Maine Medical Center Research Institute.
Bones are in a constant state of remodeling, but after age 30 or so, a woman’s
bones start to dissolve faster than they can be rebuilt, and after menopause she
may develop thin, brittle bones that are easily broken.
Bisphosphonates slow
this process. The drugs are incorporated into newly formed bone and can persist
there for years, long after a patient stops taking them. The F.D.A. report
offered little specific guidance about long-term use, saying that the decision
to continue or stop treatment should be based on an individual assessment of
risks, benefits and preferences discussed between a patient and her doctor.
The agency did say that
women at low risk for fracture or with a bone density near normal may be good
candidates to stop therapy after three to five years, but older patients at
higher fracture risk and bone density “in the osteoporotic range” may benefit
from continued therapy.
But an accompanying article
by Dr. Rosen and others, also published in The New England Journal of Medicine,
offers more specifics, concluding that the women most likely to benefit from
long-term use of the drugs are those who, after three to five years of
treatment, continue to have very low bone density, as measured by something
called a “T score” that is lower than minus 2.5. Women with a history of spinal
fracture or with an existing fracture also are most likely to benefit from
long-term use of the drugs, the researchers concluded.
However, many women who
are prescribed bone drugs have been given a diagnosis of osteopenia, moderate
to low bone density that is not low enough to be called osteoporosis. These
women are unlikely to benefit from long-term use and should probably stop
taking the drugs after about three years, the researchers said.
It is not clear how many
women would be affected based on those recommendations, but many women tire of
the therapy and stop taking it on their own anyway, partly because of
inconvenient requirements like remaining upright after taking the drugs and
common side effects of heartburn, nausea and flulike symptoms. Even so, the
researchers estimate that perhaps 60 percent to 70 percent of current users
would be candidates for stopping the drugs after three to five years.
The recommendations are
based on findings from two industry-sponsored studies led by the University of
California, San Francisco, that focused on long-term use of the drugs. A study
of Fosamax, which is sold generically as alendronate, continued for 10 years,
and a study of Reclast, an injectable form of the drug zoledronic acid,
continued for six years. According to the F.D.A. analysis, both studies showed
significant reductions in fracture risks during the first three to four years
of use but little or no benefit with longer use.
In the Fosamax trial,
10.6 percent of Fosamax users suffered a fracture during the first three years
of use, compared with 21 percent of those in the placebo group, according to
the F.D.A. analysis. But there was no benefit seen among women who continued
the drug for the next 5 to 10 years.
In the Reclast trial,
9.8 percent of women taking the drug suffered a fracture in the first three
years of the study, compared with 20 percent of women who were taking a
placebo. By four to six years, the benefit had narrowed, with 8.6 percent of
Reclast users suffering fractures, compared with 12 percent in the placebo
group.
The two studies did not
show any increased risk of serious side effects with long-term use of
bisphosphonates, but experts say the studies simply were not large enough to
detect a relatively rare adverse event. Even so, there have been numerous case
reports of the unusual fractures and other side effects, prompting widespread
concern about the risks with long-term use.
No one knows how common
the femur fractures are, but estimates have ranged from 1 in 10,000 users to 10
in 10,000. Women should be reassured that serious complications are rare, said
Dennis M. Black, a professor of epidemiology and biostatistics at U.C.S.F. and
the lead author of the article that accompanied the F.D.A. report.
“The reality is there is
a lot of uncertainty in this situation,” Dr. Black said. “The F.D.A. report was
very general, and we tried to be much more specific and use evidence from the
best trial available. Hopefully people who are using this drug will be
reassured.” Dr. Rosen said that even though the F.D.A. report was vague on
specific recommendations, he was pleased to see the analysis published.
“It’s a very new thing
that they submit a paper to The New England Journal that presents all sides of
the argument,” Dr. Rosen said. “I think it’s a good thing, because I’ve been on
these advisory committees for years, and we get a big crowd in Washington, but
the doctors never see the results.”
A better choice is to
address the cause of bone loss in 3 simple steps as recommended by Barbara
Lagoni:
First: Supplementation
OsteoMatrix (calcium plus nutrients for the matrix of the bones)
OsteoMatrix (calcium plus nutrients for the matrix of the bones)
Vita D-3:
1000 IU (take 1 or 2 a day) Vita-D3
not only improves bone density, but studies showing helps lower risk for
cancer, alzheimers, depression, heart disease — and more.
Vita Lea
Gold: A great multi-vitamin (comes with or without Vitamin K)
Second: Diet
And changing the diet to remove those foods that deplete calcium from the bones
(sugar, refined carbs, meat, and especially soda pop).
Third: Weight-bearing exercise
Note: Following the
above 3 step advice is crucial for bone health for all women, regardless of
their risk factor. Diet, supplementing and exercise are proven to help
everyone. This study shows that one size doesn’t fit all when it comes to
deciding whether to take bone building drugs or not.
For more information on
the products recommended here, please visit our website: To Be Healthy
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& It Will Go Away!”
* These statements have not been evaluated by
the Food and Drug Administration. These products are not intended to diagnose,
treat, cure, or prevent any disease.
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