Fosamax Break Won't Up Fracture Risk
Study Shows After 5 Years of Fosamax for Osteoporosis, Some Women Can Take a Break
Dec. 26, 2006 -- After five years of taking the osteoporosisdrug Fosamax, some women will be getting a break.
That's "break" as in "drug holiday," not as in
"fracture." A U.S. clinical trial shows that women who stop taking
Fosamax after five years have no more fracture risk than women who keep on
taking the drug.
Women who stopped taking Fosamax had a little bit more bone loss than women
who kept taking it. But this increased bone loss wasn't meaningful.
"For many women, discontinuation of [Fosamax] for up to five years does
not appear to significantly increase fracture risk," conclude Dennis M.
Black, PhD, of the University of California, San Francisco, and colleagues in
the Dec. 27 issue of The Journal of the American Medical
Fosamax is a member of a family of drugs called bisphosphonates. Other
members of this family are Actonel and Boniva.
"It appears that for some women, five years of bisphosphonate therapy
may be enough to realize fracture reduction benefits," notes Duke
University researcher Cathleen S. Colón-Emeric, MD, in an editorial
accompanying the study.
There was a slightly increased risk of spine fracture, so women who've had
previous vertebral fractures shouldn't stop taking Fosamax.
"Women at very high risk of clinical vertebral fractures may benefit by
continuing beyond five years," Black and colleagues suggest.
No woman taking Fosamax should stop taking the drug without talking to her
doctor. Even if a doctor says it's OK to take a Fosamax holiday, close
monitoring is needed.
Fosamax, Osteoporosis, and Fracture Risk
The study by Black and colleagues is an extension of one of the clinical
trials that led to Fosamax's approval. In the extended study, 329 women
continued taking Fosamax after five years of treatment. An additional 437 women
who'd taken Fosamax for five years got identical looking, inactive placebo
pills for the next five years.
The women who stopped taking Fosamax averaged 2.4% lower bone
density at their hip and 3.7% lower bone density at their spine. But
in both places, their bone density remained higher than before they started
Fosamax treatment 10 years earlier.
Moreover, a look at how many women got hip fractures showed no increased
risk from stopping Fosamax. However, women who continued taking Fosamax had
fewer spinal fractures.
In her editorial, Colón-Emeric notes that it's still not clear when -- or
whether -- women who take a Fosamax "holiday" should resume taking the