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Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista(R) (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis
Date:3/23/2009

Results from the "NEXT" Study Also Showed Arzoxifene Significantly Suppressed Bone Turnover Markers versus Raloxifene in Postmenopausal Women with Osteoporosis

ATHENS, Greece, March 23 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) presented new data showing arzoxifene, an investigational selective estrogen receptor modulator (SERM), was superior to raloxifene at increasing bone mineral density (BMD) in the lumbar spine, total hip and femoral neck, and at suppressing bone turnover as assessed by serum markers of bone metabolism. In this study of 320 patients, more women reported bronchitis and nasopharyngitis in the arzoxifene group versus the raloxifene group, whereas significantly fewer women reported new or worsening hot flushes in the arzoxifene group. The data were presented at the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO) annual meeting.

Arzoxifene is being studied for the prevention and treatment of osteoporosis in postmenopausal women and the reduction of risk of invasive breast cancer in postmenopausal women with osteoporosis or low bone mass.

About the "NEXT" Study

Arzoxifene versus Raloxifene: 12-month Effects on Bone Mineral Density, Bone Turnover Markers, and Safety Parameters in Postmenopausal Women with Osteoporosis

This Phase III trial, powered to show superiority, was a double-blind, active comparator, controlled, 12-month study. In the study, 320 postmenopausal women with osteoporosis were randomized to receive arzoxifene 20 mg/day (N= 158) or raloxifene hydrochloride 60 mg/day (N= 162). In addition, supplements containing 500 mg/day calcium and 400-600 IU/day vitamin D were provided. The study's primary endpoint was lumbar spine BMD. Secondary objectives included assessment of femo
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SOURCE Eli Lilly and Company
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