California-based Amgen and Belgium-based UCB reported positive results from their phase 2 clinical study comparing sclerostin-antibody AMG 785/CDP7851 to placebo in postmenopausal women with low bone mineral density (BMD) for the treatment of postmenopausal osteoporosis (PMO). The 12-month phase 2 study is a multi-center, international, randomized, placebo-controlled and parallel-group study.
This phase 2 study met its primary endpoint, demonstrating significant increases in lumbar spine bone mineral density at month 12 for the AMG 785/CDP7851 active arms versus the placebo arm. In addition, AMG 785/CDP7851 compared positively with the two active comparators, teriparatide and alendronate.
Adverse events were generally balanced between groups. Consistent with previous studies, injection site reactions were reported more frequently in those patients receiving AMG 785/CDP7851.