Parathyroid hormone receives FDA approval

In November, the FDA approved teriparatide (Forteo^®), a parathyroid hormone, for the treatment of osteoporosis in women who are postmenopausal and men with primary or hypogonadal osteoporosis. This approval is based on data from 24 clinical trials, including a phase III trial (Neer, et al. N Engl J Med 344: 1434, 2001) demonstrating the ability of PTH to reduce the risk of both vertebral and nonvertebral fractures in addition to stimulating bone formation and increasing bone mass.

Specifically, teriparatide is indicated as a second-line therapy in patients with a history of osteoporosis-related fracture, or who have multiple risk factors for fracture, or who have demonstrated intolerance to or failure with previous osteoporosis therapy. Additionally, because of the development of osteosarcomas in test rodents, the FDA has required the product carry a black box warning in the label noting the possible increased risk of developing this cancer. No osteosarcomas have been reported in any of the 2800 postmenopausal women and men participating in the above-mentioned clinical trials.