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The entire study is 21 months long; the active treatment period is 18 months with a 6- month followup period.

Competing interests: All authors have completed the ICMJE uniform disclosure form at and declare: MJB is the recipient of a Sir Charles Hercus health research fellowship; IRR has received research grants and honorariums from Merck, Amgen, Lilly, and Novartis.

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Bisphosphonates can offer substantial clinical benefit in conditions in which an imbalance between osteoblast-mediated bone formation and osteoclast-mediated bone resorption underlies disease pathology; however, the more recently recognized association of bisphosphonate use with pathologic conditions, including low bone turnover states with resultant pathologic fractures, osteonecrosis of the jaw (ONJ), and an increased incidence of atrial fibrillation, has brought increased scrutiny to the current broad use of bisphosphonate therapy.

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The results from the first 18 months of the APPROVe study did not show an increased relative risk of adverse cardiovascular events.

In some of the case reports, the symptoms resolved upon cessation of the alendronate administration.

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Serum 25-hydroxyvitamin D concentrations were not measured at baseline but were obtained from available medical records of study participants who had a measurement at any time within 3 months of study participation.

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