A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

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

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab

Criteria

Inclusion Criteria:

• Subject has provided informed consent prior to any study-specific activities/procedures

• Ambulatory postmenopausal women.

• Age 55 years or older

• Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.

Exclusion Criteria:

• Administration of osteoporosis treatments or bone active treatments within specific timeframes

• Vitamin D deficiency

• Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)

• Contraindications to denosumab therapy (e.g., hypocalcemia)