Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis

Summary

Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.

Timeline

Start

2002-06

Primary completion

2007-05

Completion

2007-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Risedronate; p <0.0001; Least Square (LS) Mean Difference 4.53 (95% CI 3.46 to 5.60); ANOVA NCT00619957 ↗

Publications

• Boonen S, Lorenc RS, Wenderoth D, Stoner KJ, Eusebio R, Orwoll ES. Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. Bone. 2012 Sep;51(3):383-8. doi: 10.1016/j.bone.2012.06.016. Epub 2012 Jun 30.

Drugs

Indications