Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

• Status: Completed
• Trial end date: 2017-06-29
• Target enrollment: 0
• Participant gender: Female

Summary

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

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

Details

• Lead Sponsor: Amgen
• Treatments: Alendronate; Antibodies, Monoclonal

Criteria

Inclusion Criteria:

Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:

• BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:

• at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral fracture OR

• at least 2 mild (SQ1) vertebral fractures OR

• BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:

• at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR

• a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.

Exclusion Criteria:

• 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

• Possible signs of intolerance to alendronate