FDA approves novel osteoporosis treatment. (First Agent to Stimulate Bone Formation).

The Food and Drug Administration has approved the first osteoporosis treatment that stimulates new bone formation.

Teriparatide, manufactured by Eli Lilly & Co. and marketed as Forteo, is a portion of human parathyroid hormone, which is the primary regulator of calcium and phosphate metabolism in bone. Up to now, osteoporosis treatments were limited to antiresorptives, which work primarily to slow or stop bone loss by reducing the number and action of bone-removing osteoclast cells. Teriparatide stimulates new bone formation by increasing the number and action of bone-forming osteoblast cells.

Teriparatide was approved to treat osteoporosis in postmenopausal women at high risk of fracture and to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk. The prime candidates for teriparatide therapy are those who have had a fracture before, have multiple risk factors for osteoporosis, have not responded to other osteoporosis treatments, or who have very low bone density, said Dr. Bess Dawson-Hughes, a member of Lilly's national science advisory board.

Teriparatide is administered by injection once a day in the thigh or abdomen in a 20-[mu]g dose. As an aid in administration, it is available in a pen similar to those used for insulin injections. The pen contains a month's worth of injections and has a very fine-gauge needle, said Dr. Dawson-Hughs, professor of medicine at Tufts University, Boston.

In a pivotal trial involving 1,637 postmenopausal women, those who received teriparatide experienced a 65% reduction in new vertebral fractures, compared with placebo during an average of 19 months of treatment. New nonvertebral fractures were reduced by 53%. Among women on teriparatide, 96% had an increase in bone mineral density (BMD), compared with women on ...