Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

• Status: Completed
• Trial end date: 2016-12-28
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

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

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab

Criteria

Inclusion Criteria:

• Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)

Exclusion Criteria:

• BMD T-score of ≤ -3.50 at the total hip or femoral neck

• History of hip fracture

• Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays

• 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