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Senior Citizen Health & Medicine
Older Women may Take Break From Osteoporosis Drug
Alendronate without Losing Benefit
Good news for postmenopausal women to avoid
indefinite treatment
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JAMA Video |
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Alendronate So Effective In Improving Bone Strength, May Keep
Working After Women Quit Taking It.
12/26/06
»1 min 45 sec
Windows
Video
Quicktime
Video |
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December 26, 2006 - Most postmenopausal women who
took the osteoporosis drug alendronate for 5 years and then stopped did
not have an increased risk for nonvertebral fractures in the next five
years, suggesting the medication has a lasting effect, according to a
study in the December 27 issue of JAMA.
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Read the latest news on Senior
Health & Medicine |
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Osteoporosis is common among postmenopausal women.
The disease is characterized by increased bone turnover (when aging bone
is broken down faster than it can be replaced), progressive loss of bone
mass and increased fracture risk. Bisphosphonates are the most commonly
used medications for postmenopausal osteoporosis, according to
background information in the article.
Alendronate, a potent bisphosphonate, decreases
bone turnover, increases bone mineral density (BMD), and decreases
vertebral, nonspine, and hip fracture risk in women with osteoporosis.
Treatment for osteoporosis often continues
indefinitely, but few studies have examined the effects of using
bisphosphonates longer than 5 years or the effects of stopping treatment
after 5 years. Some studies have suggested that stopping treatment after
several years might result in continued effectiveness because of a
residual effect of the drug, but the magnitude and duration of this
remains uncertain.
The Fracture Intervention Trial (FIT), a
randomized, blinded, placebo-controlled trial, examined the effect of
daily alendronate on BMD and fracture risk in postmenopausal women with
low BMD. Average follow-up during treatment was 3.8 years, with optional
open-label treatment continuation after trial completion.
In this article, Dennis M. Black, Ph.D., of the
University of California, San Francisco, and colleagues report data from
the FIT Long-term Extension (FLEX), which was designed to evaluate the
effects on BMD of either continuation of alendronate, 5 or 10 mg/d for a
total of 10 years, or discontinuation after approximately 5 years.
The trial was conducted at 10 clinical centers, and
1,099 postmenopausal women were randomized to: alendronate, 5 mg/d (n =
329) or 10 mg/d (n = 333), or placebo (n = 437) for 5 years (1998-2003).
The researchers found that compared with continuing
alendronate, switching to placebo for 5 years resulted in declines in
BMD at the total hip (-2.4 percent) and spine (-3.7 percent), but
average levels remained at or above pretreatment levels 10 years
earlier.
Similarly, those discontinuing alendronate had
increased serum markers of bone turnover compared with continuing
alendronate, but after 5 years without therapy, bone marker levels
remained somewhat below pretreatment levels 10 years earlier. After 5
years, the cumulative risk of nonvertebral fractures was not
significantly different between those continuing (19 percent) and
discontinuing (18.9 percent) alendronate.
Among those who continued, there was a 55 percent
lower risk of clinically recognized vertebral fractures.
...the BMD and bone marker changes suggest some
residual effect from 5 years of alendronate treatment that is evident
for at least 5 years after discontinuation, the authors write.
We conclude that continuation of alendronate
(either 5 or 10 mg/d) for 10 years maintains bone mass and reduces bone
remodeling [continuous turnover of bone mineral] compared with
discontinuation after 5 years.
"The results confirm the safety of alendronate for
up to 10 years including no increased fracture risk with long-term
alendronate use. However, even among those who discontinued therapy
after 5 years, BMD remained at or above baseline values 10 years earlier
and bone turnover was still somewhat reduced.
"Discontinuation did not increase the risk of
nonvertebral fractures or x-raydetected vertebral fractures over the
next 5 years, but the risk of clinically diagnosed vertebral fractures
was significantly increased among those who discontinued.
These results suggest that for many women,
discontinuation of alendronate after 5 years for up to 5 more years does
not significantly increase fracture risk, but women at high risk of
clinical vertebral fractures, such as those with vertebral fracture or
very low BMD, may benefit by continuing beyond 5 years, the researchers
write.
EDITORIAL: Ten vs. Five years of bisphosphonate
treatment for postmenopausal osteoporosis enough of a good thing
In an accompanying editorial, Cathleen S.
Colon-Emeric, M.D., M.H.Sc., of Duke University Medical Center, Durham,
N.C. comments on the findings of the study by Black and colleagues.
The FLEX trial has several important clinical
implications.
"First, women who have a good response to 5 years
of bisphosphonate therapy (3 percent - 5 percent increase in hip BMD, 8
percent - 10 percent increase in spine BMD ...) and are not otherwise at
increased risk of vertebral fracture can consider a holiday period of
up to 5 years without therapy. This strategy would clearly improve the
reported cost-effectiveness of bisphosphonates.
"However, the importance of careful BMD monitoring
is increased in such women; those rapidly losing BMD will likely require
resumption of bisphosphonate therapy or a switch to an alternative
agent.
Findings from FIT and similar trials established
that starting bisphosphonate therapy in postmenopausal women with
osteoporosis or a low-trauma fracture substantially reduces their risk
of vertebral and nonvertebral fractures, pain, and disability. Now,
armed with FLEX data, physicians may be able to begin telling women when
they have had enough of a good thing, Dr. Colon-Emeric writes.
Editor's Note: Dr. Colon-Emeric reports that she
has received research funding and consultancy funding from Novartis
Pharmaceuticals.
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