drugset / Trial / NCT05677152
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Phase 2
Recruiting
80 enrolled
AUVA Traumazentrum Vienna Site UKH Meidling
Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA · collab
RandomizedParallel-groupDouble-blindTreatment
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.,
Timeline
- Start
- 2022-08-22
- Primary completion
- 2025-07
- Completion
- 2030-12
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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Zoledronic acid | Other / unclassified | 5 mg | Intravenous |
Indications
No indication recorded.