Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder

NCT05677152 | Recruiting Phase 2

• 1 other identifier: ZORRO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, placebo-controlled, non-comparative, phase II study to evaluate the influence of an adjuvant, intravenous therapy with zoledronic acid (single dose) on healing after arthroscopic repair of chronic rotator cuff tears. The study including its financial support was approved by the medical director of the General Accident Insurance Institution (AUVA) , Dr. Roland Frank. Hypothesis to prove: Adjuvant intravenous therapy with zoledronic acid does improve tendon healing after arthroscopic reconstruction of chronic rotator cuff tears compared to a control group without adjuvant therapy with zoledronic acid.,

Conditions

Orthopedics; Traumatology

Keywords

zoledronic acid; chronic rotator cuff tears; arthroscopic repair

Outcome Measures

Primary Outcomes (1)

• Tendon integrity of the rotator cuff by means of magnetic resonance imaging.

  postoperative anatomically regular tendon thickness comparable to an intact tendon.

  8 years

Study Arms (2)

Zoledronic Acid

ACTIVE COMPARATOR

zoledronic acid 5 mg (Aclasta®) administered as single intravenous infusion (100 ml): Verum

Drug: Intravenous Infusion of Aclasta®

physiological saline solution 0.9%

PLACEBO COMPARATOR

Sodium chloride (physiological saline solution 0.9%) administered as single intravenous infusion (100 ml): Placebo

Drug: Intravenous Infusion of Aclasta®

Interventions

Intravenous Infusion of Aclasta® DRUG

Intravenous Infusion of Aclasta® (Verum) or physiological saline solution 0.9% (Placebo)

Zoledronic Acid; physiological saline solution 0.9%

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 and 70 years
• Magnetic resonance imaging verified rotator cuff tear (within 6 month prior to surgery)
• Rupture size with a maximum diameter of 3 cm
• Willingness to participate in the study
• Willingness to participate in a unified physiotherapy with use of a shoulder abduction pad for four weeks postoperativel

You may not qualify if:

• Patients younger than 50 or older than 70 years of age
• Pregnancy
• Known allergy to zoledronic acid or other components of the medicinal product
• Previous fracture of the affected shoulder
• Previous surgery of the affected shoulder
• Previous or existing bacterial infection of the affected shoulder
• Rupture of more than two tendons in the affected shoulder (massive rotator cuff tear)
• Isolated subscapularis tendon tear
• Presence of glenohumeral osteoarthritis (Hamada type 3 or higher)
• Diabetes mellitus (fasting glucose ≥ 126 mg/dl, HbA1C ≥ ZORRO Version Draft1.0/09.05.2022 Page 6 of 42 6.5%)
• Malignant tumor disease
• Pathological dental status
• Known disease that interferes with bone metabolism
• Concomitant diseases that do not permit general anesthesia
• Previous therapy with anti-osteoporotic drugs (bisphosphonates, denosumab, teriparatide)

Sponsors & Collaborators

• AUVA Traumazentrum Vienna Site UKH Meidling: lead
• Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA: collaborator
• CCSRM Clinical Center for Studies in Regenerative Medicine in cooperation with the Ludwig Boltzmann Institute for Traumatology: collaborator

Study Sites (1)

Jakob Schanda

Vienna, 1120, Austria

RECRUITING

Related Publications (1)

• Schanda JE, Ullrich R, Boesmueller S, Mittermayr R, Bruell T, Hexel M, Heuberer PR, Woisetschlaeger G, Neuper OM, Redl H, Grillari J, Fialka C. Intraoperative Zoledronic Acid for Arthroscopic Rotator Cuff Repair: Short-Term Results From a Prospective, Randomized, Placebo-Controlled Phase II Trial. Am J Sports Med. 2026 Jan 18:3635465251399167. doi: 10.1177/03635465251399167. Online ahead of print.

  PMID: 41549490 DERIVED

Study Officials

• Jakob Schanda, DDr.

  AUVA Traumazentrum Vienna Site UKH Meidling

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Schanda, DDr.

CONTACT

+435939345201; jakob.schanda@auva.at

Ortrun Neuper, MSc.

CONTACT

+436764543334; oneuper@trauma.lbg.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In this trial, zoledronic acid or placebo will be administered once immediately before arthroscopic rotator cuff repair. Randomization will take place. immediately before surgery by the anesthesiologist using sealed envelopes. To simplify the study procedure, zoledronic acid 5 mg (Aclasta®), administered as single intravenous infusion (verum) or sodium chloride (physiological saline solution 0.9%), administered as single intravenous infusion (placebo) will be administered preoperatively by the anesthesiologist after induction of anesthesia. Thereby, patients and surgeons are blinded to the randomization process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: placebo controlled trial (Zoledronic acid versus Placebo), randomized, 2 Teams: unblinded and blinded

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: January 10, 2023
• Study Start: August 22, 2022
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)