Bone drug tested to save knees after ACL injury – but trial stalls
NCT ID NCT05204836
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tested whether a single infusion of zoledronic acid, a drug used for osteoporosis, could improve bone health and slow joint damage after an ACL tear. Only 4 people were enrolled before the trial was terminated, so the results are very limited. The study aimed to see changes in bone structure and joint health over 6 to 18 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Zoledronic acid injection
- What this could lead to
- If this approach worked, it might help prevent long-term joint damage after ACL injuries.
- What could go wrong
- This was a very small, early-phase trial that was terminated early, so we have little data. The drug also has known side effects like bone pain and kidney issues.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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4 people
The number who actually took part.
- Started
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May 2023
- Finished
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Jul 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
-
25 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Clinical evidence of an acute unilateral ACL tear (full-thickness, complete tear) will be recruited. This age range is chosen to ensure participants have fully developed adult bone structures and to exclude participants with menopause as this could affect study results. * Participants with combined ligament deficiencies (posterior cruciate, medial and/or lateral collateral) or meniscal injury will be included. Participants must be able to fully extend the knee while supported at the time of the baseline measurement in order to conduct the HR-pQCT scan. * Participants with a serum calcium level in the normal range (2.10-2.60 mmol/L) and a creatinine level above 59 (reported as eGFR) will be included. Exclusion Criteria: * Individuals with contraindications to zoledronic acid (see below) * Prior knee ligament and/or meniscus tears, and/or intra-articular fractures. * Females who are pregnant or planning pregnancy within a year will not be eligible. The research team will recommend participants who are planning to become pregnant within the next five years to withdraw their participation. * Individuals with knees larger than the CT scanner's circular field of view. * Individuals with a history of disease and/or treatment affecting bone turnover in the past 12 months. * Individuals with injuries or implants that are not MRI-safe. Zoledronic acid is contraindicated for: * Patients who are hypersensitive to this drug or to any ingredient in the formulation, or to any bisphosphonates or component of the container. * Severe renal impairment with creatinine clearance \<35 mL/min and in those with evidence of acute renal impairment. For this study, participants with a creatinine clearance \<50 mL/min may be excluded. * Non-corrected hypocalcaemia at the time of infusion. * Pregnant and nursing mothers. * Patients who are already taking another bisphosphonate (ex. for osteoporosis).
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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
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University of Calgary
Calgary, Alberta, T2N 1N4, Canada
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Other studies related to the condition(s) this trial covers.
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