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

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

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.

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)