Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

Exclusion Criteria

• •Received other osteoporosis treatment or bone active treatment
• •Evidence of history of any of the following:
• •* hyperthyroidism (stable on antithyroid therapy is allowed)
• •* hypothyroidism (stable on thyroid replacement therapy is allowed)
• •* hypo- or hyperparathyroidism
• •* hypo- or hypercalcemia based on the central laboratory reference ranges
• •* Recent tooth extraction (within 6 months of screening visit)
• •* Paget disease of bone (subject report or chart review)
• •* other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review)
• •Abnormalities of the following per central laboratory reference ranges:
• •* vitamin D deficiency (25\[OH\] vitamin D level \< 20 ng/mL), repletion will be allowed and subjects may be re-screened
• •* hypercalcemia
• •* elevated transaminases ≥ 2.0 x upper limits of normal (ULN)
• •History of any solid organ or bone marrow transplant
• •Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years
• •Known intolerance to calcium or vitamin D supplements
• •Self-reported alcohol or drug abuse within 12 months prior to screening
• •Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
• •History or evidence of any other clinically significant disorder, condition or disease that in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion