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Bone drug tested to save knees after ACL injury – but trial stalls

NCT ID NCT05204836

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 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

4 people

The number who actually took part.

Started

May 2023

Finished

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

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: * 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.

Anterior Cruciate Ligament Injuries osteoarthritis, knee

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Calgary

    Calgary, Alberta, T2N 1N4, Canada

More trials for these conditions

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