FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Os... ( Multi-national study compared FORTE...)

FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis

Date:11/14/2007

Multi-national study compared FORTEO and the currently approved therapy

Fosamax for the treatment of Glucocorticoid-Induced Osteoporosis

INDIANAPOLIS, Nov. 14 /PRNewswire-FirstCall/ -- New data, published today in The New England Journal of Medicine, showed that in patients with glucocorticoid-induced osteoporosis FORTEO(R) (PTH 1-34, teriparatide [rDNA origin] injection) significantly increased lumbar spine bone mineral density (BMD) from baseline (8.2 percent) compared to Fosamax(R) (alendronate, 3.9 percent) at 18 months of therapy.(1)

In this head-to-head comparator study, the increase in lumbar spine BMD was significantly greater in patients receiving teriparatide compared with alendronate at 6, 12, and 18 months of treatment (p < 0.001 at all time points).(1)

Glucocorticoid therapy is the most common cause of secondary osteoporosis,(2) leading to bone loss and an increased risk for fracture. Data indicate that glucocorticoids are used by up to three out of every 100 adults (3 percent) over age 50,(3) and up to 50 percent of individuals on chronic glucocorticoid therapy will eventually have an osteoporotic fracture.(4) Glucocorticoids are prescribed to treat many conditions, including rheumatoid arthritis, chronic obstructive pulmonary disease and inflammatory bowel disease.(4,5)

"Currently, there is a lack of variety in treatment choices for patients receiving chronic glucocorticoid medication who are at high risk for fractures," said lead investigator Kenneth G. Saag, M.D., MSc, professor of medicine and epidemiology at the University of Alabama in Birmingham. "These data are important because they show that teriparatide may have the potential to be a viable therapeutic option in the future for people with this disease."

Teriparatide is not indicated for the treatment of glucocorticoid-induced osteoporosis. Teriparatide is the first osteoporosis therapy approved by the U.S. Food and Drug Administration (FDA) and the
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