Menu
Recruiting NCT05677152

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

Phase II Interventional Orthopedics Traumatology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous Infusion of Aclasta®.
Who it may be relevant to
Registry conditions: Orthopedics, Traumatology. Basic parameters: 50 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial

Overview

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.,

Interventions

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

Primary outcome measures

  • Tendon integrity of the rotator cuff by means of magnetic resonance imaging. [Time frame: 8 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Epilepsy
  • Claustrophobia
  • Chronic alcohol abuse
  • Drug abuse

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Jakob Schanda — Vienna

Publications

  • Schanda JE, Hackl M, Bischl R, Ullrich R, Boesmueller S, Mittermayr R, Redl H, Grillari J, Fialka C. Intraoperative Zoledronic Acid for Arthroscopic Rotator Cuff Repair Results in Distinct Circulating Micro-RNA Profiles Indicating Improved Tendon-to-Bone Healing. Am J Sports Med. 2026 Jun 18:3635465261455031. doi: 10.1177/03635465261455031. Online ahead of print. PMID 42316896
  • 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 Feb;54(2):342-352. doi: 10.1177/03635465251399167. Epub 2026 Jan 18. PMID 41549490

Identifiers

NCT: NCT05677152 · ZORRO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗