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FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis
Date:11/14/2007

European Medicines Agency (EMEA) that rebuilds bone in postmenopausal women with osteoporosis who are at high risk for fracture and increases bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.(5,6) Teriparatide is marketed as FORSTEO in the European Union.

In February and June 2007, Lilly filed applications with the FDA and EMEA, respectively, for a supplemental indication for teriparatide for the treatment of men and women with osteoporosis associated with glucocorticoid therapy and who are at high risk for fracture. These patients either have a history of osteoporotic fracture or low bone mineral density.(7)

About the Study

In a double-blind, active comparator-controlled trial, 428 patients with glucocorticoid-induced osteoporosis were randomized to receive once-daily subcutaneous injections of teriparatide (20 micrograms) plus oral placebo or daily placebo injections plus once-daily oral alendronate (10 mg). The study's primary endpoint was to determine whether the increase in lumbar spine bone mineral density from baseline to 18 months in patients receiving teriparatide was greater than in patients receiving alendronate.(1) Data published in the current issue of The New England Journal of Medicine represent the 18-month primary phase results of this 36-month trial. The 18- month continuation phase is ongoing.

The study included men and women aged greater than or equal to 21 years on sustained glucocorticoid therapy (prednisone equivalent of greater than or equal to 5 mg/day for greater than or equal to 3 months). Patient's spine or hip T-scores were either -2.0 or less, or -1.0 or less with one or more fractures.(1)

Efficacy data after 18-months of therapy:(1)

-- The mean increase in lumbar spine BMD with teriparatide was

significantly greater compared with Fosamax after six months through

18 months of therapy

-- 8.2 plus or minus 0.6 percent increase w
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SOURCE Eli Lilly and Company
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