Overview
Sponsor-declared trial summary
Trauma (rupture of a tendon)
Longitudinal investigation of zoledronic acid on tendon integrity via magnetic resonance imaging at six, twelve, twentyfour and sixty months after arthroscopic repair of chronic rotator cuff lesions. Null hypothesis: Adjuvant intravenous therapy with zoledronic acid does not improve tendon healing after arthroscopic re…
Key facts
- Sponsor
- AUVA Trauma Center Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2025-01-14
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AUVA Trauma Center Vienna
External identifiers
- EU CT number
- 2024-519082-22-00
- EudraCT number
- 2022-001750-29
- ClinicalTrials.gov
- NCT03584542
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Therapy, Efficacy, Safety
Longitudinal investigation of zoledronic acid on tendon integrity via magnetic resonance imaging at six, twelve, twentyfour and sixty months after arthroscopic repair of chronic rotator cuff lesions.
Null hypothesis: Adjuvant intravenous therapy with zoledronic acid does not improve tendon healing after arthroscopic reconstruction of chronic rotator cuff tears compared to a control group without adjuvant therapy with zoledronic acid.
Secondary objectives 1
- Longitudinal assessment of the rotator cuff muscles by magnetic resonance imaging at six months, twelve months, twentyfour months and sixty months postoperatively. Furthermore, the clinical function of both shoulders will be evaluated preoperatively and longitudinally at four weeks, three months, six months, twelve months, twentyfour months and sixty months postoperatively by clinical examination, strength measurement, and specific clinical and functional questionnaires. In addition, bone metabolism will be assessed by standard blood sampling preoperatively and longitudinally at three months, six months, and twelve months postoperatively to document the efficacy of zoledronic acid in the intervention group. To investigate the muscular regeneration by zoledronic acid, special blood samples for the determination of mircro ribonucleic acids will be taken preoperatively, two days postoperatively before discharge from hospital, and three months postoperatively.
Conditions and MedDRA coding
Trauma (rupture of a tendon)
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A prospective, randomized, placebo-controlled phase II-trial – ZORRO Influence of zoledronic acid on healing after arthroscopic repair of chronic rotator cuff lesions
Planned total duration: 8 years.
First patient first visit until last patient last visit: Q3/2022 – Q4/2030
Verum and Placebo-Group, 40 patients in each group.
|
Randomised Controlled | Double | [{"id":87594,"code":1,"name":"Subject"},{"id":87595,"code":3,"name":"Monitor"},{"id":87593,"code":2,"name":"Investigator"}] | Zoledronic Acid: Aclasta® (Novartis, Basel, Switzerland) 5 mg solution for intravenous application as 100 ml infusion single-dose treatment. physiological saline solution 0.9% (Placebo): sodium chloride (physiological saline solution 0.9%) administered as single intravenous infusion (100 ml) (placebo) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Age between 50 and 70 years Magnetic resonance imaging verified rotator cuff tear (within 6 months 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 postoperatively
Exclusion criteria 1
- 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 ≥ 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Tendon integrity 6 months postoperative (no re-rupture/re-rupture) Tendon integrity 12, 24 and 60 months postoperative (no re-rupture/re-rupture)
Secondary endpoints 1
- Fatty muscle infiltration, shoulder abduction and adduction, shoulder anteversion and retroversion, shoulder rotation internal and external, shoulder strength, pain evaluation, Constant-Murley-Score, American Shoulder and Elbow Surgeons Score, Subjective Shoulder Value
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1097208 · ATC
- Active substance
- Zoledronic Acid
- Substance synonyms
- ZOLEDRONATE
- Route of administration
- INFUSION
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M05BA08 — ZOLEDRONIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
—
SCP1023586 · ATC
- Route of administration
- INFUSION
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AUVA Trauma Center Vienna
- Sponsor organisation
- AUVA Trauma Center Vienna
- Address
- Kundratstrasse 37
- City
- Vienna
- Postcode
- 1120
- Country
- Austria
Scientific contact point
- Organisation
- AUVA Trauma Center Vienna
- Contact name
- DDr. Jakob Schanda
Public contact point
- Organisation
- AUVA Trauma Center Vienna
- Contact name
- DDr. Jakob Schanda
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Clinical Study Protocol ZORRO Version final 12 07 24 | 1 |
| Recruitment arrangements (for publication) | Clinical Study Protocol ZORRO Version final 12 07 24 | 1 |
| Subject information and informed consent form (for publication) | Informed Consent ZORRO final 120724 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Aclasta5 mg Infusionslosung Fachinformation September 2021 | 1 |
| Synopsis of the protocol (for publication) | synopsis and study design 2024 519082 22 00 AUVA 161024 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Austria | Acceptable 2024-12-06
|
2025-01-14 |