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Biopsies taken in patients after 3 years of Zol had significantly lower median activation frequency, mineralizing surfaces, and bone formation rate (volume referent) than biopsies from patients in the placebo group.

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Although the power of the study to detect a reduction in the risk of nonvertebral fracture was modest, rates of nonvertebral fracture were consistently lower among men who received zoledronic acid than among those who received placebo, and the point estimates were similar to the significant risk reductions in larger studies involving women.

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Consequences of sustaining a fracture may be serious and include increased risk of subsequent fractures, hospitalization or institutionalization, decreased quality of life, and premature mortality, with a related burden on the health care system.

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The number of patients who had any of the five most frequently reported symptoms after the first infusion was significantly higher in the zoledronic-acid group than in the placebo group, but the number with symptoms after subsequent infusions decreased substantially.

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