Altering Bone Microarchitecture and Mechanics by Off-label Pharmaceutical Intervention Following an Acute Knee Injury
NCT ID: NCT05204836
Last Updated: 2025-12-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE1
Total Enrollment
4 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-05-16
Study Completion Date
2025-07-03
Brief Summary
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The purpose of this study is to assess if a zoledronic acid injection can alter the trajectory of joint degeneration following an acute anterior cruciate ligament (ACL) injury.
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Detailed Description
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After being informed about the study and potential risks and all participants giving written informed consent, this project will establish a cohort of young men and women who within six weeks have sustained an acute rupture of the ACL. The cohort is randomized into a control and treatment group, where the treatment group receives a zoledronic acid injection at baseline. The cohort will be followed radiographically with high resolution peripheral quantitative computed tomography (HR-pQCT), dual-energy computed tomography (DECT), digital radiography (X-Ray), bi-planar X-ray (EOS) and magnetic resonance imaging (MRI) for eighteen months to monitor the progression of joint changes and the effects of zoledronic acid.
Conditions
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Anterior Cruciate Ligament Tear
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Injuries
Osteo Arthritis Knee
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The cohort is randomized into a control and treatment group, where the treatment group receives a zoledronic acid injection within 6 weeks of ACL injury.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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Zoledronic Acid Injection
Participants will receive 1 dose of 5 mg/100 mL intravenous zoledronic acid
Group Type
EXPERIMENTAL
Zoledronic Acid Injection
Intervention Type
DRUG
5 mg / 100 mL intravenous infusion
Placebo
Participants will receive 1 dose 100 ml Saline.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
100 mL intravenous infusion
Interventions
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Zoledronic Acid Injection
5 mg / 100 mL intravenous infusion
Intervention Type
DRUG
Placebo
100 mL intravenous infusion
Intervention Type
DRUG
Other Intervention Names
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Taro-Zoledronic Acid
Dr. Reddy's Zoledronic Acid Injection
Saline
Eligibility Criteria
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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.
* 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).
* 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).
Minimum Eligible Age
25 Years
Maximum Eligible Age
45 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Calgary
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Steven Boyd, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Gregory Kline, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Calgary
Calgary, Alberta, Canada
Site Status
Countries
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Canada
References
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Other Identifiers
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REB21-1109
Identifier Type: -
Identifier Source: org_study_id
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