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). 

Related Articles

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. 

For more information visit or