6/28/23, 12:51 AM Alendronate phase III osteoporosis treatment study Pathway Feedback Search Clinical Topics Home Studies Alendronate phase III osteoporosis treatment study Alendronate phase III osteoporosis treatment study Disease Postmenopausal osteoporosis Trial question What is the role of alendronate therapy in postmenopausal women with osteoporosis? Study design Multi-center Double blinded RCT Population 994 female patients Inclusion criteria: postmenopausal women with osteoporosis Key exclusion criteria: treatment with corticosteroids, vitamin D deficiency, Paget's disease, or hyperparathyroidism, active peptic ulcer disease, abnormal renal function, or abnormal hepatic function Interventions N=526 alendronate (5 or 10 mg daily for three years, or 20 mg for two years followed by 5 mg for one year) N=355 placebo (matching placebo) Primary outcome New vertebral fractures 6.2 % 6.2 4.7 % 3.2 3.1 % Significant decrease 1.6 % https://web.pathway.md/studies/recyncjM6mETorYo6 1/2 6/28/23, 12:51 AM Alendronate phase III osteoporosis treatment study Pathway NNT = 33 0.0 % Alendronate Placebo Significant decrease in new vertebral fractures (3.2% vs. 6.2%; RR 0.52, 95% CI 0.28 to 0.95) Secondary outcomes Significant decrease in progression of vertebral deformities (33% vs. 41%; RR 0.8, 95% CI 0.09 to 1.51) Safety outcomes No significant difference in adverse events. Conclusion In postmenopausal women with osteoporosis, alendronate was superior to placebo with respect to new vertebral fractures. Reference Liberman UA, Weiss SR, Broll J et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med. 1995 Nov 30;333(22):1437-43. Open reference URL https://web.pathway.md/studies/recyncjM6mETorYo6 2/2