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

nd 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.

Additional findings included:

  • patients treated with FORTEO had a greater average increase in BMD at the lumbar spine (+7.80 +/- 0.5 percent vs. +2.63 +/- 0.5 percent in risedronate-treated patients; p<0.001) and at the femoral neck (+2.11 +/- 0.4 percent vs. +0.77 +/- 0.4 percent, respectively; p=0.02) at 18 months;[1]
  • patients in the FORTEO group had significantly less height loss compared to the risedronate group at 18 months (0.44 centimeters vs. 0.70 centimeters; p<0.05).[1]

"The study provides additional information regarding the use of FORTEO in patients who are considered at high risk for osteoporotic fractures," said Bruce Mitlak, M.D., Distinguished Medical Fellow, Bone Muscle and Joint Platform, Eli Lilly and Company. "The results may help guide healthcare professionals in treating severe osteoporosis."

In the study, the overall safety profile was consistent with the known FORTEO safety profile seen in this patient population.[1] The overall incidence of serious adverse events, treatment-emergent adverse events and adverse events leading to discontinuation were similar between the FORTEO and risedronate treatment groups.[1]  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.[1]

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