RESEARCH - Early discontinuation of Fosamax (alendronate) may not raise fracture risk

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Early discontinuation of alendronate may not raise fracture risk

12/27/2006

By: Reuters Health

NEW YORK (Reuters Health), Dec 27 - As a treatment for postmenopausal

osteoporosis, using alendronate for 5 years rather than 10 does not seem to

increase the risk of most fractures, new research shows.

The exception is clinical vertebral fractures and, therefore, 10 years of

alendronate may be recommended for women at very high risk for such

fractures, according to the report in the December 27th issue of the Journal

of the American Medical Association.

The optimal duration of alendronate therapy is unclear. However,

pharmacokinetic studies have shown that bisphosphonates remains active in

bone for many years, suggesting that long-term treatment with alendronate

may be unnecessary.

In the Fracture Intervention Trial (FIT) Long-term Extension (FLEX), Dr.

Dennis M. Black, from the University of California at San Francisco, and

colleagues assessed BMD and fracture occurrence in 1,099 postmenopausal

women who had been treated with alendronate for a mean of 5 years and were

then randomized to alendronate (5 or 10 mg) or placebo daily for a further 5

years.

Discontinuing alendronate after 5 years was associated with moderate

reductions in BMD at the total hip and spine. However, the values were still

greater than pretreatment levels measured 10 years earlier. Similarly, early

discontinuation of the drug was associated with an increase in markers of

bone turnover, yet the values did not reach those seen prior to treatment.

Patients taking alendronate for just 5 years had nearly the same rate of

nonvertebral fractures as those who took the drug for 10 years, roughly 19%.

By contrast, early discontinuation seemed to increase the rate of clinically

recognized vertebral fractures: 5.3% vs. 2.4%. No significant effect on

morphometric vertebral fractures was noted.

The results support the long-term safety and efficacy of alendronate for

postmenopausal osteoporosis, but suggest that shorter durations of therapy

may be suitable for some women, the researchers conclude.

" 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, " Dr. Cathleen S. Colon-Emeric,

from Duke University in Durham, North Carolina, writes in an accompanying

editorial. " Now, armed with FLEX data, physicians may be able to begin

telling women when they have had enough of a good thing. "

Last Updated: 2006-12-26 16:00:31 -0400 (Reuters Health)

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