6/28/23, 12:51 AM Alendronate for osteoporosis in men Pathway Feedback Search Clinical Topics Home Studies Alendronate for osteoporosis in men Alendronate for osteoporosis in men Disease Osteoporosis Trial question What is the role of alendronate in male patients with osteoporosis? Study design Multi-center Double blinded RCT Population 241 male patients Inclusion criteria: male patients with osteoporosis Key exclusion criteria: medical conditions associated with bone loss or other bone diseases, vitamin D deficiency, renal disease, severe cardiac disease, or history of treatment for osteoporosis Interventions N=146 alendronate (10 mg daily for up to2 years) N=95 placebo (matching placebo daily for up to 2 years) Primary outcome Gain in bone mineral density at lumbar spine at 2 years 7.1 7.1 % 5.3 % 3.5 % Significant increase 1.8 1 8 % https://web.pathway.md/studies/recYKWhVlZDa7trYi 1/2 6/28/23, 12:51 AM Alendronate for osteoporosis in men Pathway 8 1.8 % NNH = 19 0.0 % Alendronate Placebo Significant increase in gain in bone mineral density at the lumbar spine at 2 years (7.1% vs. 1.8%; ARD 5.3, 95% CI 4.3 to 6.3) Secondary outcomes Significant decrease in vertebral fractures (0.8% vs. 7.1%; RR 0.11, 95% CI 0.02 to 0.2) Significant increase in bone mineral density at the total body at 2 years (2% vs. 0.4%; AD 1.6%, 95% CI 1 to 2.1) Conclusion In male patients with osteoporosis, alendronate was superior to placebo with respect to gain in bone mineral density at the lumbar spine at 2 years. Reference Orwoll E, Ettinger M, Weiss S et al. Alendronate for the treatment of osteoporosis in men. N Engl J Med. 2000 Aug 31;343(9):604-10. Open reference URL https://web.pathway.md/studies/recYKWhVlZDa7trYi 2/2