Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer

NCT04549207 · tracked via the Priya Life Science Canada tracker

Sponsor

Ottawa Hospital Research Institute

Phase

Phase 4

Started

2020-10-09

Last updated

2026-07-21

Condition(s) studied

Breast CancerCastration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

Bone modifying agent →

Bone modifying agent: Use of bone modifying agent

Study summary

The investigators propose to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and castration-resistant prostate cancer

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer or breast cancer who are currently receiving BMA * Patient has received BMA for 2 or more years counting from the first BMA dose for bone metastases * Age 18 years or older * Able to provide verbal consent Exclusion Criteria: * Definite contraindication for BMA * History of, or current evidence of osteonecrosis of the jaw * Radiotherapy or surgery to the bone planned within 4 weeks after randomization * Current hypercalcemia defined as corrected serum calcium of \> 3 mmol/L (from standard bloodwork completed within one month prior to treatment dose)

Primary outcome measure(s)

Health related quality of life scores — 48 weeks after randomization (one year of treatment)
Health related quality of life (HR-QoL) scores measured by the European Organisation for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-C30 physical functioning subscale and the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire (QLQ)- for patients with bone metastasis (BM)22 functional interference subscale. The EORTC-QLQ-C30 is an internationally accepted and validated tool in multiple large study cohorts capturing HR-QoL from a multi-dimensional and global perspective in oncology. EORTC-QLQ-BM22 has been validated for use specifically in bone metastases. They were developed in collaboration with patients, healthcare professionals and thorough review of the literature, and therefore important to all stakeholders; the scales are well-defined and easily measured, and HR-QoL is a relevant goal of care in the palliative care setting.

Trial sites (5)

Facility	City	Region
William Osler Health System	Brampton	Ontario
London Health Sciences Centre	London	Ontario
Southlake Regional Health Centre	Newmarket	Ontario
The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04549207 on ClinicalTrials.gov ↗ ← All trials in Canada