In Reply: Serious events reported in this study
were defined in accordance with regulatory guidelines.1
As noted in Table 3 of our article, the overall incidence of serious adverse
events reported was similar between the placebo (27%) and 5-mg risedronate
We performed a safety analysis focusing on major cardiovascular events
reported during the study. Based on this analysis, the most common events
occurred at similar incidences between treatment groups. Cardiovascular events
reported at a cumulative incidence of more than 1% were right heart failure
(placebo, 1.6%; risedronate, 1.8%), myocardial infarction (placebo, 1.6%;
risedronate, 1.5%), and cerebrovascular accident (placebo, 1.0%; risedronate,
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