6/30/23, 12:51 AM Zoledronate for osteopenia Pathway Feedback Search Clinical Topics Home Studies Zoledronate for osteopenia Zoledronate for osteopenia Disease Postmenopausal osteoporosis Trial question What is the role of zoledronate in fracture prevention in postmenopausal women with osteopenia? Study design Multi-center Double blinded RCT Population 2000 female patients Inclusion criteria: postmenopausal women with osteopenia Key exclusion criteria: an eGFR of < 30 mL/min/1.73 m of body-surface area, major systemic disease, cancer in the previous 2 years, metabolic bone disease, or regular use bone-active drugs in the previous year, and prednisone at a dose of 2.5 mg per day Interventions N=1000 zoledronate (four infusions of 5 mg at 18-month interval) N=1000 placebo (four infusions of normal saline at 18-month interval) Primary outcome Fragility fracture 19.0 % 19 14.3 % 12.2 9.5 % Significant decrease 4.8 % NNT = 15 0.0 % Zoledronate Placebo https://web.pathway.md/studies/recqztel2OWPdx3qI 1/2 6/30/23, 12:51 AM Zoledronate for osteopenia Pathway Significant decrease in fragility fracture (12.2% vs. 19%; HR 0.63, 95% CI 0.5 to 0.79) Secondary outcomes Significant decrease in height loss by at least 1 cm (32.2% vs. 41.3%; OR 0.67, 95% CI 0.55 to 0.82) Safety outcomes No significant difference in serious adverse events included fractures that resulted in hospitalization. Significant differences in serious adverse events (820 vs. 1017; OR 0.84, 95% CI 0.70-1.00). Conclusion In postmenopausal women with osteopenia, zoledronate was superior to placebo with respect to fragility fracture. Reference Reid IR, Horne AM, Mihov B et al. Fracture Prevention with Zoledronate in Older Women with Osteopenia. N Engl J Med. 2018 Dec 20;379(25):2407-2416. Open reference URL https://web.pathway.md/studies/recqztel2OWPdx3qI 2/2