Abstract
SummaryThis study showed that risedronate 150-mg once a month provides similar efficacy and safety at 2 years compared with risedronate 5-mg daily for the treatment of postmenopausal osteoporosis. This adds to the range of risedronate dosing options and provides an alternative for patients who prefer once-a-month dosing.IntroductionRisedronate is effective in the treatment of postmenopausal osteoporosis in oral daily, weekly, or on two consecutive days per month doses. This 2-year randomized, double-blind, multicenter study assesses the efficacy and safety of a single risedronate 150-mg once-a-month oral dose compared with the 5-mg daily regimen.MethodsWomen with postmenopausal osteoporosis were randomly assigned to receive risedronate 5-mg daily (n = 642) or 150-mg once a month (n = 650) for 2 years. Bone mineral density (BMD), bone turnover markers, new vertebral fractures, and adverse events were evaluated. The primary efficacy endpoint was the mean percent change from baseline in lumbar spine BMD after 1 year.ResultsFour hundred ninety-eight subjects in the daily group (77.6 %) and 513 subjects in the once-a-month group (78.9 %) completed the study. After 24 months, the mean percent change in lumbar spine BMD was 3.9 % (95 % confidence interval [CI], 3.43 to 4.42 %) and 4.2 % (95 % CI, 3.68 to 4.65 %) in the daily and once-a-month groups, respectively. The once-a-month regimen was determined to be non-inferior to the daily regimen. The mean percent changes in BMD at the hip were similar in both dose groups, as were changes in biochemical markers of bone turnover. The incidence of adverse events, adverse events leading to withdrawal, and upper gastrointestinal tract adverse events were similar in the two treatment groups.ConclusionsAfter 2 years, treatment with risedronate 150-mg once a month provided similar efficacy and tolerability to daily dosing and provides an alternative for patients who prefer once-a-month oral dosing.
Highlights
The primary endpoint analysis was a test of non-inferiority comparing the least squares mean percent change from baseline in lumbar spine Bone mineral density (BMD) in the 150-mg once-amonth and 5-mg daily groups after 12 months
Baseline characteristics were similar in both treatment groups
This study was a preplanned 2-year study comparing a dose of risedronate 150-mg once a month to the 5-mg daily dose. These 2-year data show that the 150-mg once-a-month dose continues to produce clinical effects that are similar to those seen with the 5-mg daily dose
Summary
Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5-mg daily (n0642) or 150-mg once a month (n0650) for 2 years. The mean percent changes in BMD at the hip were similar in both dose groups, as were changes in biochemical markers of bone turnover. Conclusions After 2 years, treatment with risedronate 150-mg once a month provided similar efficacy and ClinicalTrials.gov identifier: NCT00247273. This randomized, double-blind, active-controlled, parallelgroup non-inferiority study was conducted at 47 study centers in the Americas, Europe, Australia, and Asia Treatments. Calcium (1,000-mg/day) and vitamin D (400– 500 IU/day) were supplied to all subjects, they were allowed to take up to 1,000 IU/day of vitamin D These supplements were taken with a meal other than breakfast and not with the study medication
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
