Evidence for safety and efficacy of risedronate in men with osteoporosis over 4Â years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study

► Risedronate significantly increases lumbar spine BMD from baseline after 4 years of treatment. ► Patients switching from placebo to 2 years of risedronate treatment show a significant increase in lumbar spine BMD from baseline. ► Few new vertebral and clinical fractures occurred during this open-label extension. ► There were no significant differences in BTMs between the two groups at months 36 and 48. ► Safety results continued to show that risedronate was well-tolerated in men with osteoporosis.