Comparison of Weekly Treatment of Postmenopausal Osteoporosis with Alendronate Versus Risedronate Over Two Years

Sydney Bonnick, Kenneth G. Saag, Douglas P. Kiel, Michael McClung, Marc Hochberg, Sherri-Ann M. Burnett, Anthony Sebba, Risa Kagan, Erluo Chen, Desmond E. Thompson, Anne E. De Papp
2007 Obstetrical and Gynecological Survey  
Objective: A 1-year extension of the FOSAMAX ® ACTONEL ® Comparison Trial (FACT) was completed to compare changes in bone mineral density (BMD), bone turnover, and upper gastrointestinal tolerability over 2 years of treatment. Design: Randomized, double-blind extension conducted at 72 US sites. Patients and Methods: Of the 1053 women who completed Year 1, 833 postmenopausal women with low BMD entered the extension, continuing their same treatment allocation (once-weekly (OW) alendronate 70 mg
more » ... alendronate 70 mg or OW risedronate 35 mg). Changes in BMD at the hip trochanter, total hip, femoral neck, and lumbar spine and in markers of bone turnover were compared at 24 months. Tolerability was assessed by adverse experience reporting. Results: Alendronate produced greater increases from baseline in BMD at 24 months than did risedronate at the trochanter (ALN, 4.6%; RIS, 2.5%, p<0.001), as well as at all other BMD sites. Significantly more alendronate than risedronate patients had measured BMD increases of ≥0% and ≥3% at all BMD sites (p<0.001), and fewer alendronate patients had measured decreases of ≥3% at all BMD sites. Significantly greater reductions in all biochemical markers of bone turnover occurred with alendronate compared with risedronate. No differences were seen in occurrence or discontinuations due to upper gastrointestinal adverse experiences. 4 Conclusions: Patients receiving OW alendronate 70 mg had greater gains in BMD, were more likely to maintain or gain BMD, and had greater reductions in bone turnover markers than patients receiving OW risedronate 35 mg after 24 months, with no differences in upper gastrointestinal tolerability.
doi:10.1097/01.ogx.0000251009.57462.83 fatcat:v6smynctana57ahpqqgkggmtc4