NCT05204836

Altering Bone Microarchitecture and Mechanics by Off-label Pharmaceutical Intervention Following an Acute Knee Injury

Altering Bone Microarchitecture and Mechanics by Off-label Pharmaceutical Intervention

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Anterior Cruciate Ligament Tear
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Injuries
• Osteo Arthritis Knee

Interventions

Type	Name	Description
DRUG	Zoledronic Acid Injection	5 mg / 100 mL intravenous infusion
DRUG	Placebo	100 mL intravenous infusion

Timeline

• Start date: 2023-05-16
• Primary completion: 2025-07-03
• Completion: 2025-07-03
• First posted: 2022-01-24
• Last updated: 2025-12-02

Locations

1 site across 1 country: Canada