Odanacatib: Phase III data

The double-blind, international Phase III LOFT trial in 19,713 postmenopausal women with osteoporosis who were receiving vitamin D and calcium showed that once-weekly 50 mg odanacatib met the co-primary endpoints of reducing the risk of osteoporotic hip fractures (47% relative risk reduction), new and worsening morphometric vertebral fractures (54% relative risk reduction) and non-vertebral fractures (23% relative risk reduction) vs. placebo (p<0.001 for all). Odanacatib also met the secondary endpoint of reducing the risk of vertebral fractures vs. placebo (72% relative risk reduction, p<0.001). Additionally, odanacatib increased BMD from baseline to 5 years compared to placebo by 11.2% at the lumbar spine and by 9.5% at the total hip (p<0.001 for both).

The rates of adverse events were generally balanced between treatment arms. Adjudicated events of morphea-like skin lesions and atypical femoral shift fractures occurred more frequently in the odanacatib arm compared to the placebo arm. Furthermore, there were numerically more adjudicated stroke events with odanacatib than with placebo. Data were presented at the American Society for Bone and Mineral Research meeting in Houston. ...