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Lilly Announces Study Results Regarding Postmenopausal Women with Back Pain Caused by Vertebral Fractures
Date:8/7/2012

TEO is used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones (fractures). FORTEO is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures). FORTEO can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.[2]

During the drug testing process, the medicine in FORTEO caused some rats to develop osteosarcoma, which, in humans, is a serious but rare bone cancer. Osteosarcoma has been reported rarely in people who took FORTEO, and it is unknown if people who take FORTEO have a higher chance of getting the disease. Before patients take FORTEO, patients should tell their healthcare provider if they have Paget's disease of bone, are a child or young adult whose bones are still growing or have had radiation therapy.[2] For more information about FORTEO, please see the important safety information, including Boxed Warning regarding osteosarcoma, below.

About the Study[1]

"The Effect of Teriparatide Compared with Risedronate on Reduction of Back Pain in Postmenopausal Women with Osteoporotic Vertebral Fractures" was a Phase III, prospective, randomized, double-blind, double-dummy, active-controlled, 18-month trial involving 710 postmenopausal women with at least one moderate or severe vertebral fracture thought to be the cause of back pain. The primary objective was to compare the efficacy of FORTEO (20 micrograms/day) and risedronate (35 milligrams/week) based on the proportion of women who reported a 30 percent or greater reduction in worst back pain severity, as assessed by an 11-point numeric rating scale (0=no pain; 10=severe pain), from baseline to six months of therapy. Pre-specified secondary and exploratory outcomes included assessments of average and worst
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SOURCE Eli Lilly and Company
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