Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Inclusion Criteria:

Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)

Exclusion Criteria:

• Severe osteoporosis
• Use of agents affecting bone metabolism
• History of metabolic or bone disease (except osteoporosis)
• Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
• Current hyper- or hypocalcemia
• Current, uncontrolled hyper- or hypothyroidism
• Current, uncontrolled hyper- or hypoparathyroidism