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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

ZAPOA Trial 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.Check my eligibility

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.See study design

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.

ZAPOA Trial 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.

ZAPOA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

ZAPOA 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,098 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being added to this medical experiment?

"Unfortunately, this medical trial is no longer recruiting as per the information on clinicaltrials.gov; it was first published on December 1st 2023 and last updated November 1st 2022. Fortunately, there are 1160 other studies actively welcoming participants at present."

Answered by AI

Does your experiment include participants aged thirty and above?

"This clinical trial seeks participants aged 25 to 45 years old."

Answered by AI

Does the FDA permit the utilization of Zoledronic Acid Injection?

"Our team rated the safety of Zoledronic Acid Injection a 1 since this is still an early-stage trial, so data has not been fully compiled to assess both its efficacy and caution."

Answered by AI

What is the ultimate intention of this research project?

"The primary goal of this trial, observed over the period from baseline to two months, is to assess changes in bone microarchitecture at six months with high resolution peripheral quantitative computed tomography (HR-pQCT). Secondary objectives include gathering patient reported outcomes using the ACL Quality of Life Questionnaire and Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaires both at 2 and 6 months."

Answered by AI

Is there a way I can become involved in this trial?

"This research project is looking for 56 individuals between the ages of 25 and 45 who have sustained a tear in their anterior cruciate ligament. For consideration, candidates must fit these prerequisites."

Answered by AI

Recent research and studies

British Journal of Sports MedicineJournal

Knee Osteoarthritis Risk Is Increased 4-6 Fold After Knee Injury – a Systematic Review and Meta-analysis

Poulsen, Erik, Glaucia H Goncalves, Alessio Bricca, Ewa M Roos, Jonas B Thorlund, and Carsten B Juhl. 2019. “Knee Osteoarthritis Risk Is Increased 4-6 Fold After Knee Injury – a Systematic Review and Meta-analysis”. British Journal of Sports Medicine. BMJ. doi:10.1136/bjsports-2018-100022.

Annals of the Rheumatic DiseasesJournal

The Global Burden of Hip and Knee Osteoarthritis: Estimates from the Global Burden of Disease 2010 Study

Cross, Marita, Emma Smith, Damian Hoy, Sandra Nolte, Ilana Ackerman, Marlene Fransen, Lisa Bridgett, et al.. 2014. “The Global Burden of Hip and Knee Osteoarthritis: Estimates from the Global Burden of Disease 2010 Study”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2013-204763.

Osteoporosis InternationalJournal

Guidelines for the Assessment of Bone Density and Microarchitecture in Vivo Using High-resolution Peripheral Quantitative Computed Tomography

Whittier, D.E., S.K. Boyd, A.J. Burghardt, J. Paccou, A. Ghasem-Zadeh, R. Chapurlat, K. Engelke, and M.L. Bouxsein. 2020. “Guidelines for the Assessment of Bone Density and Microarchitecture in Vivo Using High-resolution Peripheral Quantitative Computed Tomography”. Osteoporosis International. Springer Science and Business Media LLC. doi:10.1007/s00198-020-05438-5.

BoneJournal