56 Participants Needed

Zoledronic Acid for Anterior Cruciate Ligament Injury

(ZAPOA Trial)

SB
Overseen BySteven Boyd, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Calgary

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

SB

Steven Boyd, PhD

Principal Investigator

University of Calgary

GK

Gregory Kline, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have injuries to my knee's ligaments or meniscus.
I can fully straighten my knee when it's supported.
I have a completely torn ACL in one knee.
See 1 more

Exclusion Criteria

Pregnant and nursing mothers
I have severe kidney problems or my kidneys are not working well right now.
I have had previous knee injuries, including ligament or meniscus tears, or fractures within the joint.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a zoledronic acid injection at baseline

1 day
1 visit (in-person)

Monitoring

Participants are monitored radiographically with HR-pQCT, DECT, X-Ray, EOS, and MRI to assess joint changes and effects of zoledronic acid

18 months
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • Zoledronic Acid Injection
Trial Overview 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.
How Is the Trial Designed?
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+
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