Eli Lilly and Co. (LLY) reported data from a Phase III trial comparing the effects of FORTEO and risedronate on back pain in postmenopausal women with osteoporotic vertebral fractures. The study demonstrated 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.
However, there were statistically significant differences in favor of FORTEO in some exploratory measures, including greater increases in bone mineral density and fewer patients with new vertebral fractures. The trial results are published in the August issue of Osteoporosis International.
The overall safety profile of the study was consistent with the known FORTEO safety profile seen in this patient population, as well as the overall incidence of serious adverse events, treatment-emergent adverse events and adverse events resulting in discontinuation were similar between the FORTEO and risedronate treatment groups. There were nine deaths in the study, four in the FORTEO group and five in the risedronate group, but none of the deaths were considered related to treatment, the company said.
by RTT Staff Writer
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