Lilly reports encouraging results form Phase III osteoporosis trial

Eli Lilly and Company has reported promising new data from Phase III Next trial which showed that arzoxifene, an investigational selective estrogen receptor modulator, was superior to raloxifene at increasing bone mineral density 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.

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 20mg/day (N= 158) or raloxifene hydrochloride 60mg/day (N= 162).

In addition, supplements containing 500mg/day calcium and 400-600IU/day vitamin D were provided. The study’s primary endpoint was lumbar spine bone mineral density (BMD). Secondary objectives included assessment of femoral neck and total hip BMD, serum bone turnover markers, mammographic breast density and safety. The study included postmenopausal women with osteoporosis with a mean age of 63 years and a mean lumbar spine BMD T-score of -2.9.

Adrien Sipos, medical director at Eli Lilly and Company, said: 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. 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.