Eli Lilly and Company 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.

"The significant increases in BMD and suppression of markers of bone turnover seen in these data show the potential benefits of arzoxifene for the treatment of osteoporosis in postmenopausal women," said investigator Jose Zanchetta, specialist in osteology and mineral metabolism, Metabolic Research Institute, Buenos Aires, Argentina. "I am encouraged by these results and interested in seeing the next phase-III data for arzoxifene."

These data are from the 'NEXT' Study, the second of three phase-III trials for arzoxifene. In September 2008, results from the 'Foundations' phase-III prevention study were first presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Montréal. The third phase-III trial, the 'Generations' Study, is a five-year, randomized, double-blind, placebo-controlled study assessing the effects of arzoxifene on vertebral fracture incidence and on invasive breast cancer incidence in postmenopausal women with osteoporosis or with low bone density. Results from that trial are anticipated in late 2009.

"We are pleased with the results of the 'NEXT' Study and its implications for arzoxifene as a potential treatment option for postmenopausal women with osteoporosis," said Adrien Sipos, medical director for Eli Lilly. "We are committed to research that will help bring innovative prevention and treatment options to patients suffering from this devastating disease, which affects one in three women over 50."