Odanacatib: Phase II data

A double-blind Phase II trial in 243 postmenopausal women with osteoporosis who had previously been treated with alendronate for >=3 years showed that once-weekly 50 mg odanacatib met the primary endpoint of increasing BMD at the femoral neck from baseline to 24 months vs. placebo (1.73% vs. a 0.94% reduction). Odanacatib also met the secondary endpoints of increasing BMD at the hip trochanter (1.83% vs. a 1.35% reduction), total hip (0.83% vs. a 1.87% reduction) and lumbar spine (2.28% vs. a 0.3% reduction) from baseline to 24 months vs. placebo. Odanacatib missed the secondary endpoint of increasing BMD at the distal forearm from baseline to 24 months vs. placebo (0.92% reduction vs. a 1.14% reduction). The overall incidence of adverse events was similar between treatment groups and the most common adverse events were urinary tract infection (UTI), back pain, arthralgia, fractures, bronchitis, nasal pharyngitis and upper respiratory infection. All patients received vitamin D and calcium supplements if needed. Data were presented at the American Society for Bone and Mineral Research meeting in Minneapolis. ...