Objectives: To evaluate overall and upper gastrointestinal (UGI) tolerability of once-weekly (OW) alendronate and OW risedronate in a posthoc subgroup analysis of patients above and below age 65. Methods: The FOSAMAX® ACTONEL® Comparison Trial (FACT) was a 1 year, randomized, double-blind, double-dummy study comparing OW alendronate and OW risedronate. Postmenopausal women with osteoporosis (BMD T-score £-2.0 at the total hip, hip trochanter, femoral neck, or lumbar spine) were randomized (1:1) to OW alendronate 70 mg or OW risedronate 35 mg. Rates of overall adverse experiences (AEs) and UGI AEs were analyzed for standard AE categories in subgroups of patients <65 and ³65 years. A Breslow-Day test for interaction between treatment and age was performed for overall AEs and UGI AEs. Results: Of 1053 patients, 545 (51.8%) were <65 years and 508 (48.2%) were ³65 years. There were no significant interactions between treatment and age for overall AEs (p=0.444) or UGI AEs (p=0.595). There were no significant differences between treatments within each age subgroup. In the subgroup <65 years, patients treated with alendronate and risedronate, respectively, had similar rates of overall AEs (76.0% vs 77.2%), serious AEs (4.9% vs 5.9%), and discontinuations due to AEs (4.1% vs 5.9%), as well as UGI AEs (23.6% vs 19.9%), serious UGI AEs (0% vs 0.7%), and discontinuations due to UGI AEs (1.5% vs 2.9%). In the subgroup ³65 years, patients treated with alendronate and risedronate, respectively, had similar rates of overall AEs (77.0% vs 74.1%), serious AEs (12.9% vs 9.8%), and discontinuations due to AEs (8.9% vs 6.7%), as well as UGI AEs (21.4% vs 20.4%), serious UGI AEs (0% vs 0.8%), and discontinuations due to UGI AEs (3.6% vs 3.1%). Conclusions: There were no significant differences between alendronate and risedronate in overall AEs or UGI AEs within each age subgroup. OW alendronate and OW risedronate have similar safety and tolerability, regardless of patient's age.
Disclosure Information:
Faculty Member's Name: S. Broy, MD
Grants/Research Support: Merck & Co., Inc.
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