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

• Status: Completed
• Trial end date: 2015-06-17
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

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