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

April 1, 2026 updated by: Ottawa Hospital Research Institute

A Randomised Trial 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 (REaCT-Hold BMA)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital Cancer Centre
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard BMA frequency
Continue standard BMA frequency (every 4 or 12 weeks) as administered previously. If a change in BMA frequency (every 4 weeks to every 12 weeks OR every 12 weeks to every 4 weeks) was prescribed by the physician, this would still be considered on protocol treatment.
Drug: Bone modifying agent
Use of bone modifying agent
Other Names:
  • Denosumab
  • Zoledronate
  • Pamidronate
Active Comparator: De-escalate BMA to once every 24 weeks
Bone modifying agent once every 24 weeks.
Drug: Bone modifying agent
Use of bone modifying agent
Other Names:
  • Denosumab
  • Zoledronate
  • Pamidronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life scores
Time Frame: 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.
48 weeks after randomization (one year of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic Skeletal Event (SSE)
Time Frame: 2 years post-randomization
Number of patients with one or more SSEs (defined as: use of radiotherapy to relieve skeletal symtoms, new symptomatic pathological bone fractures [vertebral or non-vertebral], spinal cord compression, tumour-related orthopedic surgical intervention, or hypercalcaemia] during trial period) up to 2 years post-randomization.
2 years post-randomization
Time to development of Symptomatic Skeletal Event
Time Frame: 2 years post-randomization
Defined from the date of randomization until the first date of patient experience an SSE. Any patient who does not experience an SSE will be censored on the last follow-up date and the patient can be confirmed as SSE-free (up to 2 years).
2 years post-randomization
Symptomatic Skeletal Event-free survival
Time Frame: 2 years post-randomization
SSE-free survival (composite of time to first SSE and time to death)
2 years post-randomization
Skeletal morbidity
Time Frame: 2 years post-randomization
Skeletal morbidity rate defined as ration of number of SSEs for each subject divided by the subject's time at risk in years.
2 years post-randomization
Quality of life of cancer patients using the EORTC-QLQ-C30
Time Frame: 48 weeks post-randomization
Assess quality of life of cancer patients using the EORTC-QLQ-C30 (cancer patient specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment")
48 weeks post-randomization
Quality of life of cancer patients using the EORTC-QLQ-BM22
Time Frame: 48 weeks post-randomization
Assess quality of life of cancer patients using the EORTC-QLQ-BM22 (patients with bone metastases specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment")
48 weeks post-randomization
BMA-related toxicity rates
Time Frame: 2 years post-randomization
BMA-related toxicity rates (up to 2 years) based on standard of care blood tests and clinical assessments
2 years post-randomization
Incremental cost-effectiveness rations
Time Frame: 2 years post-randomization
Defined as the difference in cost between two possible interventions, divided by the difference in their Quality Adjusted Life Year (QALY) gained.
2 years post-randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of subsequent de-escalation or discontinuation of BMAs
Time Frame: 2 years post-randomization
In the continuation arm, frequency of subsequent de-escalation or discontinuation of BMAs
2 years post-randomization
Frequency of restarting standard dosing BMA
Time Frame: 2 years post-randomization
In the de-escalation arm, frequency of restarting standard dosing BMA (and the reasons for restarting)
2 years post-randomization
Overall survival
Time Frame: 2 years post-randomization
Overall survival during study duration
2 years post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Terry Ng, MD, Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2020

Primary Completion (Actual)

April 17, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REaCT-Hold BMA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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