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Risedronate use for 2 years or 4 years improves bone properties in osteoporotic men
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In a 2-year randomized study with a 2-year open -label extension, osteoporotic men who received risedronate once weekly for 2 years had similar results with the regimen as those who took the same dose of risedronate over 4 years, according to recent study results.
More than 280 patients diagnosed with osteoporosis or lumbar spine were initially enrolled in the 2-year, randomized, double-blind, placebo-controlled study and treated either with risedronate (Actonel; Warner Chilcott) 35 mg or placebo once weekly. Researchers, to continue their assessment of the drug’s safety and efficacy in this patient population, extended the study through a 2-year, open-label extension.
In the open-label extension, 218 patients in the original study were prescribed 35 mg risedronate once weekly, as well as a daily calcium and vitamin D supplement. Investigators tracked adverse events (AEs), laboratory data, vital signs, and physical examination results to evaluate the safety of risedronate. They also determined bone mineral density (BMD) levels, and the presence of bone turnover markers (BTM) and any new vertebral fractures to evaluate the medication’s efficacy.
Researchers observed continued, significant increases in lumbar spine BMD from baseline among the patients who took risedronate for 4 years and among patients who took it for 2 years. Study results showed few new vertebral and clinical fractures and no significant differences in BTM between the groups at 36 months and 48 months.
Overall, atrial fibrillation was the most common serious AE, but in the men prescribed risedronate for 4 years, nasopharyngitis constituted the most common AE. Concerning AEs during the extension period, the incidence of upper gastrointestinal AEs was low and similar between the two study groups; however, the percent of moderate to severe AEs was higher in the group that received the placebo before beginning the extension of the study.
“The results from this study are important because there are limited safety and efficacy data from controlled studies in men with osteoporosis, and these findings provide up to 4 years of safety and efficacy data with risedronate in this population,” the researchers stated in the study.
Disclosure: The study was funded by Warner Chilcott LLC, and Sanofi. The researchers reported receiving grants for research support from Amgen, Lilly, Merck, Proctor & Gamble Pharmaceuticals, Sanofi, Servier, Warner Chilcott and Wright Medical Technologies; consulting fees from Warner Chilcott and Sanofi; owning stock in Proctor & Gamble; and being employed by Warner Chilcott and Proctor & Gamble.
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