4,093 postmenopausal women with osteoporosis and a fragility fracture
Participants were randomized to the following cohorts
Received monthly subcutaneous romosozumab (210 mg) followed by open-label alendronate
Weekly oral alendronate (70 mg) for 12 months followed by open-label alendronate
Patients received daily calcium and vitamin D
Primary outcomes at 24 months
Cumulative incidence of new vertebral fractures
Cumulative incidence of clinical fracture (nonvertebral and symptomatic vertebral fracture)
Incidences of nonvertebral and hip fracture at the time of the primary analysis
Serious cardiovascular adverse events, osteonecrosis of the jaw, and atypical femoral fractures
Romosozumab rapidly increased bone mineral density by 6 months
Comparing Romosozumab-to-alendronate group to alendronate-only group, the Romosozumab-to-alendronate group had
48% lower risk of new vertebral fractures (6.2% [127 of 2046 patients]) (p< 0.001)
Fewer clinical fractures (9.7% vs. 13.0%) representing a 27% lower risk (p<0.001)
19% lower risk of nonvertebral fractures (8.7% vs. 10.6%; P=0.04)
38% lower risk of hip fracture (2.0% vs. 3.2%; P=0.02)
No significant difference in overall adverse and serious adverse events
During year 1, positively adjudicated serious cardiovascular adverse events were observed more often with romosozumab (2.5%) than with alendronate (1.9%) with an odds ratio [OR] of 1.31 (95% CI 0.85 to 2.00)
A total of 16 patients (0.8%) in the romosozumab group and 6 (0.3%) in the alendronate group reported cardiac ischemic events (OR 2.65; 95% CI 1.03 to 6.77)
16 patients (0.8%) in the romosozumab group and 7 (0.3%) in the alendronate group reported cerebrovascular events (OR, 2.27; 95% CI 0.93 to 5.22)
Comparable and low risk of osteonecrosis of the jaw (1 event each) and atypical femoral fracture was observed in both romosozumab-to-alendronate and alendronate groups (2 and 4 events respectively)
In postmenopausal women with osteoporosis and at high risk for fracture, romosozumab and alendronate treatment lowered fracture risk
This study identified an imbalance in serious cardiovascular adverse events in comparison with alendronate
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