Safety and Efficacy of Risedronate in Reducing Fracture Risk in Osteoporotic Women Aged 80 and Older: Implications for the Use of Antiresorptive Agents in the Old and Oldest Old

• Published in: Journal of the American Geriatrics Society (JAGS) 2004-11, Vol.52 (11), p.1832-1839
• Main Authors: Boonen, Steven, McClung, Michael R., Eastell, Richard, El-Hajj Fuleihan, Ghada, Barton, Ian P., Delmas, Pierre
• Format: Article
• Language: English
• Subjects: Aged; aged 80 and older; Aged, 80 and over; Biological and medical sciences; Bone Remodeling; Bones; Calcium Channel Blockers - adverse effects; Calcium Channel Blockers - therapeutic use; Clinical trials; Crossnational studies; Diseases of the osteoarticular system; Double-Blind Method; Drug therapy; Drugs; Elderly women; Etidronic Acid - adverse effects; Etidronic Acid - analogs & derivatives; Etidronic Acid - therapeutic use; Female; Fractures; General aspects; Geriatrics; Humans; Medical sciences; Osteoporosis; Osteoporosis, Postmenopausal - complications; Osteoporosis, Postmenopausal - drug therapy; Osteoporosis. Osteomalacia. Paget disease; postmenopausal osteoporosis; Proportional Hazards Models; Randomized controlled trials; Risedronate; Risedronate Sodium; Risk; Risk reduction; Spinal Fractures - etiology; Spinal Fractures - prevention & control; Treatment; Treatment Outcome; Very old
• ISSN: 0002-8614; 1532-5415
• DOI: 10.1111/j.1532-5415.2004.52506.x

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 Intervention 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 Australia. Participants: Osteoporotic (femoral neck bone mineral 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 1,000 mg/d calcium and, if baseline levels were low, up to 500 IU/d vitamin D. Measurements: Cumulative incidence of new vertebral fractures. Results: After 1 year, the risk of new vertebral fractures in the risedronate group was 81% lower than with placebo (95% confidence interval=60–91%; P