Health & Fitness

WELLNESS

T

Concern About
Bisphosphonates?

here recently has become great
concern about the long-term safety
of some osteoporosis drugs, spe-
cifically those in the bisphosphonate class
of drugs.
The bisphosphonates are used to slow
down bone loss and increase bone density
and thereby reduce the risk of fracture in
patients who have osteoporosis. Clinicians
have been prescribing these drugs for the
treatment of osteoporosis for many years.
The first of its kind, alendronate, which
is marketed under the name Fosamax, was
approved for the treatment of osteoporosis
in 1995. Since that time, millions of men
and women have taken these drugs and
have done quite well with them. Most
patients do not have any side effects and,
if they do, it tends to be irritation of the
upper intestinal tract, i.e., the esophagus
and stomach.
This drug, like its successors in the class,
has prevented many a patient from having
fragility fractures, which is the worst out
come of having osteoporosis. As a matter
of fact, one in two women after the age of
50 can be expected to have an osteoporotic
type fracture within their next 30 years
unless they receive some type of treatment.
Osteoporosis generally is a disease of the
aging population and primarily affects
postmenopausal women.
A few years ago, researchers started
reporting on a long-term potential com-
plication of Fosamax use — unusual
fractures of the thigh bones, i.e. the femurs.
To date, there have been about 20 reported
cases of unusual fractures of the femur
bone occurring with little or no trauma.
Of those reported cases, the majority of

the women had
been taking Fosamax; but it has also been
reported with other bisphosphonates as
well.
The research also has shown that,
typically, patients are on these drugs for at
least five years before the unusual fracture
occurs. There are various theories as to
how these drugs could cause unusual or
atypical fractures, one of which is that the
medication could be slowing down bone
remodeling so much that there is not a
normal healing and restructuring process
going on to repair microdamage in the
bone that occurs on a regular basis.
This concern about long-term bisphos-
phonate use comes on the tail of concerns
that I think were quite overblown regard-
ing the potential for osteonecrosis of the
jaw — jawbone death, with long-term use
of the bisphosphonates. All combined, if
one balances the risks versus the benefits
of the osteoporosis treatments, it clearly
indicates a far greater benefit than risk
in appropriate patients. Unfortunately,

when the down sides to treatment have
been reported in the lay press over the last
several years, they are not balancing the
benefits of treatment against these risks.
They have essentially scared patients into
stopping medication, which has great
ramifications.
Furthermore, if one does a literature
search on the Internet regarding osteopo-
rotic fractures, the top 10 results are links
to websites of attorneys who are willing to
represent patients in potential lawsuits. As
an endocrinologist who specializes in the
management of patients with osteoporosis,
I have been inundated with phone calls
and patient visits regarding concerns about
these potential side effects of treatments.
A careful review of the medical literature
suggests that the relationship between
bisphosphonate use and these atypi-
cal fractures is quite weak. A recent New
England Journal of Medicine publication
reported on an analysis of three large
randomized bisphosphonate trials, two

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52

October 28 • 2010

Gary W.
Edelson, M.D.
Columnist

This concern about long-term
bisphosphonate use comes on the
tail of concerns that I think were
quite overblown regarding the
potential for osteonecrosis of the
jaw — jawbone death.

of which involved Fosamax and one of
which involved intravenous Reclast. They
reviewed 284 records of the 14,195 treated
patients who had hip or femur fractures.
Of these, it was determined that the occur-
rence of an atypical fracture in the femur
was very rare, even among the women who
had been treated with bisphosphonates
for as long as 10 years. Their conclusion
was that there was no significant increase
in the risk of atypical fractures associated
with bisphosphonate use.
Where does it leave the patient and
where does it leave the clinician as far as
what to recommend? Nobody knows for
sure.
My personal opinion is that if the patient
has a significant enough risk for fracture
to warrant ongoing treatment, they should
not be dissuaded from continuing by the
very uncommon side effect of an atypical
fracture of the femur.
On the other hand, if patients have a
relatively low risk for fracture and have
been on a bisphosphonate drug for more
than five years, they should discuss with
their physician the possibility of stopping
the drug for some period of time — a so-
called drug holiday.
Until we have more answers, all I can say
is to the reporters and attorneys who are
fueling the fire of patient's skepticism —
"Give me a break!" Lin

Dr. Gary Edelson of Franklin is a partner

in Associated Endocrinologists of West

Bloomfield, chief of endocrinology of Sinai-

Grace Hospital and a teaching physician of

Royal Oak-based William Beaumont Hospital.

E-mail: gwedoc@comcast.net

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