Denosumab Global Safety Methodology and Background Rate Assessment and Global Safety Assessment Among Women with Postmenopausal Osteoporosis Using Multiple Observational Databases

This long term surveillance study has three primary goals: 1) to establish algorithms and identify women with postmenopausal osteoporosis; 2) to establish algorithms and identify the occurrence of adverse events of special interest, including osteonecrosis of the jaw, atypical fracture, fracture healing complications, hypocalcemia, dermatologic adverse events, infections, acute pancreatitis, hypersensitivity reaction and new primary malignancy, and 3) to examine the incidence rates of these adverse outcomes in women exposed to denosumab therapy, bisphosphonate therapy and among all women with post-menopausal osteoporosis.

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