Forteo: Phase III data

A double-blind, international Phase III trial in 710 postmenopausal women with >=1 moderate or severe vertebral fracture thought to be the cause of back pain showed once-daily 20 µg subcutaneous Forteo missed the primary endpoint of increasing the proportion of patients with a >=30% reduction in 24-hour worst back pain severity at 6 months vs. Actonel risedronate (59.2% vs. 57.4%, p=0.64). Forteo also missed the secondary and exploratory endpoints compared to Actonel of the proportion of patients with a >=30% reduction in 24-hour worst or mean back pain severity at 12 or 18 months, quality of life, disability, days of bed rest, days of disability, amount of concomitant analgesics used and the number of patients with new nonvertebral fractures. ...