A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Postmenopausal South Korean Women With Osteoporosis

The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.

Inclusion Criteria:

• Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.
• Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening.
• BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck.
• At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA.
• Other inclusion criteria may apply.

Exclusion Criteria:

• Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck.
• History of hip fracture.
• Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities.
• Known sensitivity or intolerance calcium and vitamin D products.
• Other exclusion criteria may apply.