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

• Status: Completed
• Trial end date: 2018-12-21
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

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
• 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
• 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.