A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

• Status: Completed
• Trial end date: 2014-12-08
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

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

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

Postmenopausal women with osteoporosis at high risk for fracture defined as

• BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND

• a history of fragility fracture or at least 2 other risk factors

Exclusion Criteria:

• BMD T score < -3.50 at the total hip or femoral neck.

• History of hip fracture.

• History of metabolic or bone disease (except osteoporosis).

• Use of agents affecting bone metabolism.

• Vitamin D insufficiency.

• History of solid organ or bone marrow transplants.

• Hyper- or hypocalcemia.

• Hyper- or hypothyroidism.

• Hyper- or hypoparathyroidism.