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Could a single Bone-Strengthening shot be enough for breast cancer patients?

NCT ID NCT03664687

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study tested whether a single dose of the bone drug zoledronate works as well as doses given every six months for three years in women with early-stage breast cancer. The goal was to see if a simpler schedule is feasible and could reduce side effects. The trial enrolled 211 patients and measured how quickly study sites could recruit participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zoledronate (zoledronic acid)
What this could lead to
If a single dose works as well as multiple doses, it could simplify treatment and reduce side effects for early-stage breast cancer patients.
What could go wrong
This is a small, early-phase trial focused on feasibility, not on proving the single dose is equally effective. The single dose may not protect against bone metastases as well as the standard schedule.

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

211 people

The number who actually took part.

Started

Oct 2018

Finished

Mar 2025

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: * Commencing zoledronate within 3 months of starting neoadjuvant or adjuvant endocrine therapy or within 3 months of completion of neoadjuvant or adjuvant chemotherapy for early stage breast cancer * Patients receiving any intravenous or oral biphosphonates, or subcutaneous denosumab for the treatment of osteoporosis must discontinue treatment prior to baseline evaluation * ECOG performance status equal or less than 2 and life expectancy of more than 12 months * Serum creatinine greater than 30 ml/min and corrected serum calcium equal or greater than 2 mmol/l within 4 weeks before first zoledronate infusion * Age equal or greater than 18 years * Able to provide written consent Exclusion Criteria: * Metastatic disease * History of osteonecrosis of the jaw * 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 * Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study)\* \*Women/men of child bearing potential must have agreed to use two effective contraceptive methods while on study. A women is considered to be of 'childbearing potential' if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods. 'effective contraception' also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as complete hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate participant chooses to become heterosexually active during the period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures. Examples of effective methods of contraception: Male condom plus spermicide; Cap plus spermicide; Diaphragm plus spermicide; intrauterine device (Copper T, Progesterone T; Levonorgestrel-releasing intrauterine system (i.e. Mirena); hormonal methods (implants, hormonal shot or injection, combined pill, minipill, patch).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2, Canada

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7, Canada

  • Markham Stouffville Hospital

    Markham, Ontario, L3P 7P3, Canada

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8M2, Canada

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9, Canada

  • William Osler Health System, Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7, Canada

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