Amgen and UCB announced Phase 3 clinical data showing that Evenity (romosozumab) followed by alendronate was better at reducing new vertebral, clinical, non-vertebral, and hip fracture risk in postmenopausal women with osteoporosis at high risk vs. alendronate alone. The late-breaking data were presented at the Annual Meeting of the American Society for Bone Mineral Research (ASBMR), in Denver, CO.
ARCH (Active-contRolled FraCture Study in Postmenopausal Women with Osteoporosis at High Risk of Fracture) was a multicenter, international, randomized, double-blind, alendronate-controlled study (n=4,093) in postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history.
The data showed postmenopausal women with osteoporosis treated with Evenity through 24 months had a statistically significant 48.0% relative reduction in the risk of a new vertebral fracture vs. women treated with alendronate alone (6.2% vs. 11.9%; P<0.001). Moreover, Evenity-treated patients showed a statistically significant 27.0% relative reduction in the risk of clinical fracture, which included non-vertebral and clinical vertebral fracture (9.7% vs. 13.0%; P<0.001).
With regards to the risk of non-vertebral fractures, a statistically significant 19.0% relative reduction was seen in Evenity-treated patients (8.7% vs. 10.6%; P<0.04). When compared to alendronate monotherapy, women treated with Evenity had a 38.0% relative reduction in the risk of hip fractures (2.0% vs. 3.2%; P=0.015).
Treatment with Evenity also resulted in greater bone mineral density (BMD) gains from baseline at all measured sites for all time points of the study vs. treatment with alendronate alone; significant gains were seen as early as Month 6 (P<0.001) for all sites. At Month 12, patients showed a greater percent change from baseline after receiving Evenity both at the lumbar spine (13.7% vs. 5.0%; P<0.001) and total hip (6.2% vs. 2.8%; P<0.001), when compared to alendronate.
The incidence of adverse events and serious adverse events were comparable between the treatment groups apart from the imbalanced cardiovascular serious adverse events during the 12-month period (2.5% Evenity vs. 1.9% alendronate) that were already reported.
Evenity, a bone-forming monoclonal antibody, is under investigation for its potential to lower the risk of fractures. It works by inhibiting sclerostin, allowing rapid increase in bone formation and a reduction in bone resorption at the same time.