Health and Beauty

Osteoporosis Brochure

Amgen and UCB Provide Regulatory Update on Status of EVENITY(TM) (romosozumab) in the EU

FRAME ( Fra cture study in postmenopausal wo m en with ost e oporosis) is a randomized, double-blind, placebo-controlled study that evaluated 7,180 postmenopausal women with osteoporosis. The study evaluated the efficacy of EVENITY treatment (210 mg, administered monthly), compared with placebo, in reducing the incidence of new vertebral fractures through 12 months. The study also evaluated the efficacy of treating with EVENITY for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the incidence of new vertebral fractures through 24 months.

ARCH ( A ctive-cont r olled fra c ture study in postmenopausal women with osteoporosis at h igh risk of fracture) is a randomized, double-blind, alendronate-controlled study of EVENITY in 4,093 postmenopausal women with osteoporosis and previous fracture history. This event-driven study evaluated 12 months of EVENITY treatment (210 mg, administered monthly), followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone, to assess its efficacy in reducing the risk of clinical fracture (non-vertebral fracture and symptomatic vertebral fracture) through the primary analysis period and the incidence of new vertebral fracture at 24 months.