Phase-III data, published online this week in the Journal of Clinical Endocrinology & Metabolism, showed that arzoxifene, an investigational selective estrogen receptor modulator (SERM) being developed by Eli Lilly and Company, significantly increased lumbar spine and total hip bone mineral density (BMD) in postmenopausal women with normal or low bone mass, versus placebo.
In addition, arzoxifene, dosed at 20 mg/day, decreased biochemical markers of bone turnover, and showed a neutral effect on the uterus and endometrium.
"It is encouraging that arzoxifene showed the potential of bone loss prevention, with significant gains in BMD in the spine and hip areas in postmenopausal women in this study," said lead investigator Michael Bolognese, Bethesda Health Research Center in Bethesda, Maryland. "I am pleased with the results from this study and believe that arzoxifene at 20 mg/day may be a therapeutic option worthy of continued development."
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.
These data are from the Foundation Study, one of three phase-III trials for arzoxifene. In March, data from the second phase-III trial called Next study were presented at the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO) annual meeting. 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 outcomes of this study," said Adrien Sipos medical director for Eli Lilly and Company. "As a company, we are committed to research that will help us offer patients new treatment options and further advance understanding of how to best prevent and treat osteoporosis, a disease which negatively impacts more than 200 million people worldwide."