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

NCT05204836 | Terminated Phase 1

• 1 other identifier: REB21-1109
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

acl tear; acl; acl rupture; acl injury; osteo arthritis

Outcome Measures

Primary Outcomes (2)

• Bone microarchitecture changes at 6 months as assessed by high resolution peripheral quantitative computed tomography (HR-pQCT)

  To determine morphological parameters from HR-pQCT scans, the trabecular portion must be isolated from the cortical shell of the bone in order to analyse the components separately. This is accomplished with an already developed auto-segmentation algorithm. In addition, the raw HR-pQCT images must be converted to binary images, wherein each voxel (3D pixel) is either labelled 'bone' or 'not bone.' This segmentation is performed by an algorithm which applies either a Gaussian or Laplace-Hamming filter in addition to a threshold to the grey-scale images. The binary images can then be analysed and morphological parameters can be determined. The changes in bone microarchitecture will be assessed at 6 months in comparison to baseline.

  Baseline, 6 months

• Bone microarchitecture changes at 18 months as assessed by high resolution peripheral quantitative computed tomography (HR-pQCT)

  To determine morphological parameters from HR-pQCT scans, the trabecular portion must be isolated from the cortical shell of the bone in order to analyse the components separately. This is accomplished with an already developed auto-segmentation algorithm. In addition, the raw HR-pQCT images must be converted to binary images, wherein each voxel (3D pixel) is either labelled 'bone' or 'not bone.' This segmentation is performed by an algorithm which applies either a Gaussian or Laplace-Hamming filter in addition to a threshold to the grey-scale images. The binary images can then be analysed and morphological parameters can be determined. The changes in bone microarchitecture will be assessed at 18 months in comparison to baseline.

  Baseline, 18 months

Secondary Outcomes (33)

• Bone marrow lesions (BML) and soft tissue injury changes at 2 months as assessed by Magnetic Resonance Imaging (MRI)

  Baseline, 2 months

• Bone marrow lesions (BML) and soft tissue injury changes at 2 months as assessed by Magnetic Resonance Imaging (MRI)

  Baseline, 2 months

• Bone marrow lesions (BML) and soft tissue injury changes at 2 months as assessed by Magnetic Resonance Imaging (MRI)

  Baseline, 2 months

• Bone marrow lesions (BML) and soft tissue injury changes at 2 months as assessed by Magnetic Resonance Imaging (MRI)

  Baseline, 2 months

• Bone marrow lesions (BML) and soft tissue injury changes at 6 months as assessed by MRI

  Baseline, 6 months

Study Arms (2)

Zoledronic Acid Injection

EXPERIMENTAL

Participants will receive 1 dose of 5 mg/100 mL intravenous zoledronic acid

Drug: Zoledronic Acid Injection

Placebo

PLACEBO COMPARATOR

Participants will receive 1 dose 100 ml Saline.

Drug: Placebo

Interventions

Zoledronic Acid Injection DRUG

5 mg / 100 mL intravenous infusion

Also known as: Taro-Zoledronic Acid, Dr. Reddy's Zoledronic Acid Injection

Zoledronic Acid Injection

Placebo DRUG

100 mL intravenous infusion

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

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MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Zoledronic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Steven Boyd, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Gregory Kline, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 24, 2022
• Study Start: May 16, 2023
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-09

Locations

CA (1)