4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases
NCT02721433 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 263
Last updated 2020-12-02
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.
Conditions
- Breast Cancer
- Prostate Cancer
- Metastasis
Interventions
- DRUG
-
Pamidronate
Bone-targeted agent as standard of care
- DRUG
-
Bone-targeted agent as standard of care
- DRUG
-
Zoledronate
Bone-targeted agent as standard of care
Sponsors & Collaborators
-
Ottawa Hospital Research Institute
lead OTHER
Principal Investigators
-
Mark Clemons, MD · The Ottawa Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2019-09-30
- Completion
- 2020-04-30
Countries
- Canada
Study Locations
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