Abstract:
OBJECTIVES: To determine the efficacy of risedronate in reducing vertebral fracture risk in women aged 80 and older with osteoporosis. DESIGN: Pooled analysis of data from three randomized, double-blind, controlled, 3-year-fracture-endpoint trials conducted from November 1993 to April 1998: Hip Inter-vention Program (HIP), Vertebral Efficacy with Risedronate Therapy-Multinational (VERT-MN), and VERT-North America (NA). SETTING: Office-based practices, research centers, and osteoporosis clinics in Europe, North America, and Aus-tralia. PARTICIPANTS: Osteoporotic (femoral neck bone min-eral density T-score -2.5 standard deviations or at least one prevalent vertebral fracture) women aged 80 and older. INTERVENTION: Patients received placebo (n = 688) or risedronate 5 mg-d (n = 704) for up to 3 years. All patients received 1,000mg-d calcium and, if baseline levels were low, up to 500 IU-d vitamin D. MEASUREMENTS: Cumulative incidence of new verte-bral fractures. RESULTS: After 1 year, the risk of new vertebral fractures in the risedronate group was 81 percent lower than with placebo (95percent confidence interval = 60-91percent; P.001). The num-ber of women who needed to he treated to prevent one new vertebral fracture after 1 year was 12. This early onset of efficacy was consistent across the clinical programs, and anti-fracture efficacy was confirmed over 3 years. Risedronate was well tolerated, with a safety profile comparable with that of placebo. CONCLUSION: These findings provide the first evidence that, even in the very old, reducing bone resorption rate remains an effective treatment strategy for osteopprosis. Because each therapeutic agent used for the treatment of osteoporosis may have unique characteristics, the observa-tions made in this study should not be assumed to apply to other bisphosphonates. © 2004 by the American Geriatrics Society.