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Bone-enhancing effects of alendronate sustained for decade
  NEW YORK (Reuters Health) - Alendronate's ability to inhibit bone loss and its tolerability are sustained over a 10-year period, according to a report published in The New England Journal of Medicine for March 18. However, the beneficial effects gradually disappear when the drug is discontinued.
Although the findings suggest that alendronate can be safely given for 10 years, "the optimal duration of treatment has not been established," Dr. Gordon J. Strewler, from Harvard Medical School in Boston, notes in a related editorial. "Could alendronate treatment be stopped after 10 or more years with persistent protection against fractures?"
The study involved 994 postmenopausal women who were randomized to receive alendronate at various doses for up to 10 years. Of the four treatment groups, two groups received the drug throughout the entire study period, whereas the other two received placebo at various points.
Treatment with alendronate 10-mg for 10 years was associated with significant improvements in bone mineral density (BMD) at most sites, lead author Dr. Henry G. Bone, from the Michigan Bone and Mineral Clinic in Detroit, and colleagues note.
Average baseline-to-10-year BMD increases with the 10-mg-dose included 13.7% at the lumbar spine, 10.3% at the trochanter, 5.4% at the femoral neck, and 6.7% at the total proximal femur. Less pronounced improvements were seen with the 5-mg dose.
During the first 3 years of the study, when a direct placebo comparison was available, alendronate therapy was associated with a significant anti-fracture effect (p = 0.03). Moreover, there was no evidence this benefit was lost with prolonged therapy.
The risk of adverse events did not increase significantly when alendronate was given for 10 years rather than 5. Four women treated with a 5-mg dose of alendronate died, but none of the deaths were attributed to the drug.
"Better data regarding the relative risk of fracture associated with continued treatment as compared with the discontinuation of treatment will be required for good clinical decision making," Dr. Strewler states.
N Engl J Med 2004;350:1172-1174,1189-1199.


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