NDIANAPOLIS, Aug. 7, 2012 -- Eli Lilly and Company (NYSE: LLY) today announced data from a Phase III trial comparing the effects of FORTEO® (teriparatide [rDNA origin] injection) and risedronate on back pain in postmenopausal women with osteoporotic vertebral fractures. The study showed no difference between FORTEO and risedronate on the primary endpoint of at least a 30 percent reduction in worst back pain from baseline to six months of therapy, as assessed by a numeric rating scale in each treatment group.[1] However, there were statistically significant differences in favor of FORTEO in some exploratory measures, including greater increases in bone mineral density (BMD) and fewer patients with new vertebral fractures. The results of the study are published in the August issue of Osteoporosis International.
"With many available options to treat osteoporosis, this study is important because it compares two established osteoporosis medicines in a direct head-to-head design," said lead investigator Peyman Hadji, M.D., department head, endocrinology, osteoporosis and reproductive medicine at Philipps-University of Marburg.
At six months, more than half of patients in both treatment groups reported a 30 percent or greater reduction in worst back pain (FORTEO – 59.2 percent, risedronate – 57.4 percent; p=0.64).[1] (A 30 percent or greater reduction is considered a clinically meaningful change.)[1] There were no statistically significant differences between treatments in the secondary and exploratory endpoints of at least a 30 percent reduction in worst or average back pain at six, 12 or 18 months;[1] quality of life; disability; days of bed rest; days of disability; and amount of concomitant analgesics used.
Significantly fewer patients treated with FORTEO experienced a worsening of average back pain between six and 18 months (23.6 percent vs. 30.6 percent of risedronate-treated patients; p=0.04).[1] Significantly fewer patients treated with FORTEO had one or more new vertebral fractures at 18 months (4.4 percent vs. 9.4 percent of risedronate-treated patients; p=0.01).[1] Among patients with new vertebral fractures, those treated with FORTEO had overall less severe new fractures compared to those who received risedronate, as measured by spine radiograph (p=0.04).[1] There was no significant difference between treatment groups in the number of patients with new nonvertebral fractures.
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