drugset / Trial / NCT02721433

4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases

NCT02721433

Phase 4 Completed 263 enrolled Ottawa Hospital Research Institute
RandomizedSingle-groupOpen-labelTreatment

Summary

The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs. 4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process as the study is comparing standard schedules and not a new administration schedule.

Timeline

Start
2016-08
Primary completion
2019-09
Completion
2020-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Denosumab Monoclonal antibody
Comparator Pamidronate Small molecule
Comparator Zoledronate Other / unclassified