Calendario›AMGN›denosumab
denosumab
Denosumab Safety Assessment in Multiple Observational Databases
Ensayo de AMGEN INC en Osteoporosis.
Más ensayos de: Osteoporosis.
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 517.991
- Fin del objetivo primario
- jul 2023
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en may 2010.
Qué mide
Incidence rates of Adverse Events of Special Interest (AESI) (del registro, en inglés) (hasta 10 años)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis 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.
Más ensayos de AMGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Inebilizumab | Fase 3 | En marcha, sin reclutar | abr 2024 (real) |
| inebilizumab · MINT | Fase 3 | En marcha, sin reclutar | may 2024 (real) |
| Tarlatamab · DeLLphi-304 | Fase 3 | En marcha, sin reclutar | ene 2025 (real) |
| Tarlatamab · DeLLphi-307 | Fase 2 | En marcha, sin reclutar | mar 2025 (real) |
| Maridebart Cafraglutide | Fase 2 | En marcha, sin reclutar | oct 2025 (real) |
| Erenumab Dose 1 · OASIS(EM) | Fase 3 | En marcha, sin reclutar | nov 2025 (real) |
Todos los de AMGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02520362), actualizada en oct 2024.