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

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Treatments: Denosumab; Pamidronate; Zoledronic Acid

Criteria

Inclusion Criteria:

• Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer (36) or breast cancer.

• About to start or currently receiving BTA therapy.

• Serum creatinine >30 ml/min and corrected serum calcium ≥ 2 mmol/l

• Age ≥ 18 years.

• Able to provide verbal consent

Exclusion Criteria:

• For CRPC patients - Definite contraindication for denosumab at baseline (e.g. hypocalcaemia [Albumin-corrected serum calcium < 2.0 mmol/l]).

• History of or current evidence of osteonecrosis of the jaw.

• Radiotherapy or surgery to the bone planned within 4 weeks after randomization.

• Known hypersensitivity to trial drug or hypersensitivity to any other component of the trial drug (e.g. fructose).

• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol.