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Denosumab Safety Assessment in Multiple Observational Databases

NCT02520362 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 517991

Last updated 2024-11-04

No results posted yet for this study

Summary

This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources, US Medicare, Optum Research Database (formerly United HealthCare), Scandinavian national health registry databases, including data from Denmark, Sweden, and Norway. The study period will include up to 10 years in each data system depending on data availability. Descriptive statistics will be used to characterize cohorts with respect to patient characteristics and utilization patterns. Person-year adjusted AESI incidence rates will be calculated among postmenopausal women, postmenopausal women with osteoporosis, and exposure cohorts with a final comparative safety analysis. Subsequent sub-studies using US data systems were added to describe men with osteoporosis treated with Prolia and men and women who receive Prolia with glucocorticoid exposure.

Conditions

Interventions

DRUG

denosumab

subcutaneous injection

DRUG

bisphosphonate

The assessment of bisphosphonates includes branded oral bisphosphonates (eg, alendronate \[Fosamax®\], risedronate \[Actonel®\], ibandronate \[Boniva®/Bonviva®\] oral); generic bisphosphonates, including alendronate, neridodronate, and olpadronate; intravenous bisphosphonates including ibandronate IV, and zoledronate \[Reclast®/Aclasta®\].

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Optum, Inc.

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    collaborator OTHER

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Eligibility

Min Age
30 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2023-07-21
Completion
2023-07-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520362 on ClinicalTrials.gov