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Post Menopausal Osteoperosis, Male Osteoperosis clinical trials

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NCT ID: NCT02520362 Active, not recruiting - Clinical trials for Post Menopausal Osteoperosis, Male Osteoperosis

Safety Assessment Among Women With Postmenopausal Osteoporosis and Men With Osteoporosis in Multiple Observational Databases

Start date: May 31, 2010
Phase: N/A
Study type: Observational

This is a prospective open cohort study with annual assessment and reporting of descriptive findings and a final report at the end of the study to address all study objectives. The study period will include 10 years of data accumulated in each data system. The study start date is the denosumab international birth date, 26 May 2010. The data end date will be 10 years after the international birth date, 25 May 2020.The primary data sources will be the following:• US Medicare, including Parts A, B, and D• United HealthCare• Scandinavian national health registry databases, including data from Denmark, Sweden, and Norway. Data will be collected for postmenopausal women overall, women with Postmenopausal Osteoporosis, and patients who receive Prolia for unapproved indications. Among women with Postmenopausal Osteoporosis, exposure cohorts will be established based on exposure to denosumab or bisphosphonates. Nine adverse events of special interest will be identified using validated algorithms based on inpatient and outpatient diagnosis and procedure codes, and, for some AESI, medication codes or laboratory data. Selected AESI (osteonecoris of the jaw and atypical femoral fracture) will be confirmed by medical chart review.