This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
833
Ibandronate 150mg PO QM (tablet)
denosumab 60mg SC Q6M (pre-filled syringe)
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Time frame: Baseline to month 12
Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1
Time frame: Baseline to month 1
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
Time frame: Baseline to Month 12
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Time frame: Baseline to month 12
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