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Zoledronic Acid for Anterior Cruciate Ligament Injury (ZAPOA Trial)

Phase 1
Recruiting
Led By Gregory Kline, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with combined ligament deficiencies (posterior cruciate, medial and/or lateral collateral) or meniscal injury
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
Must not have
Patients with severe renal impairment with creatinine clearance <35 mL/min or evidence of acute renal impairment
Prior knee ligament and/or meniscus tears, and/or intra-articular fractures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months

Summary

This trial will test if zoledronic acid, given as an injection, can help prevent joint degeneration after an ACL injury.

Who is the study for?
This trial is for adults with a recent, complete tear in their anterior cruciate ligament (ACL) who have normal calcium and kidney function. They can have other knee injuries too but shouldn't be pregnant or planning pregnancy soon, have past knee injuries, or conditions affecting bone turnover.
What is being tested?
The study tests if an injection of zoledronic acid can prevent joint damage after an ACL injury compared to a placebo. Participants will receive either the real drug or a placebo without knowing which one they get.
What are the potential side effects?
Zoledronic acid may cause flu-like symptoms, pain at the injection site, nausea, dizziness, and rarely jawbone problems or unusual thigh bone fractures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have injuries to my knee's ligaments or meniscus.
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I can fully straighten my knee when it's supported.
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I have a completely torn ACL in one knee.
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My calcium levels are normal and my kidney function is above 50.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe kidney problems or my kidneys are not working well right now.
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I have had previous knee injuries, including ligament or meniscus tears, or fractures within the joint.
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I am currently taking medication for osteoporosis.
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My calcium levels are low and haven't been treated yet.
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I am not pregnant and do not plan to become pregnant within a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bone microarchitecture changes at 18 months as assessed by high resolution peripheral quantitative computed tomography (HR-pQCT)
Bone microarchitecture changes at 6 months as assessed by high resolution peripheral quantitative computed tomography (HR-pQCT)
Secondary study objectives
Bone marrow lesions (BML) and soft tissue injury changes at 2 months as assessed by Magnetic Resonance Imaging (MRI)
Bone marrow lesions (BML) and soft tissue injury changes at 6 months as assessed by MRI
Knee alignment as assessed by bi-planar x-ray
+20 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Zoledronic Acid InjectionExperimental Treatment1 Intervention
Participants will receive 1 dose of 5 mg/100 mL intravenous zoledronic acid
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive 1 dose 100 ml Saline.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,327 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Injury
330 Patients Enrolled for Anterior Cruciate Ligament Injury
Gregory Kline, MDPrincipal InvestigatorUniversity of Calgary
Steven Boyd, PhDPrincipal InvestigatorUniversity of Calgary

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05204836 — Phase 1
Anterior Cruciate Ligament Injury Research Study Groups: Zoledronic Acid Injection, Placebo
Anterior Cruciate Ligament Injury Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05204836 — Phase 1
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204836 — Phase 1
~3 spots leftby Dec 2024
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