Could a single Bone-Strengthening shot be enough for breast cancer patients?
NCT ID NCT03664687
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
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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
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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 Hide 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
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Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
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Markham Stouffville Hospital
Markham, Ontario, L3P 7P3, Canada
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Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8M2, Canada
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Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
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William Osler Health System, Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
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