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Bone drug breakthrough: could less be more for cancer patients?

NCT ID NCT04549207

Symptom relief Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study looks at whether people with breast or prostate cancer that has spread to the bones can safely stop or reduce their bone-strengthening medication after taking it for at least two years. The goal is to see if this change improves their quality of life without increasing bone problems like fractures. About 240 adults are taking part, and they are randomly assigned to either continue their current treatment or reduce/stop it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

240 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm castration-resistant prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Castration-resistant prostate cancer

Contacts and locations

Locations

  • London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9, Canada

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, Canada

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4, Canada

  • William Osler Health System

    Brampton, Ontario, L6R 3J7, Canada

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