OrthopedicsPhase 2ZORRONCT05677152
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
A Phase 2 study testing Intravenous Infusion of Aclasta® in people with Orthopedics and Traumatology, run by AUVA Traumazentrum Vienna Site UKH Meidling at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Orthopedics, Traumatology
- What is being tested?
- Intravenous Infusion of Aclasta®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 22 Aug 2022to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial
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
- Being tested
- Intravenous Infusion of Aclasta®
- Keywords
- zoledronic acid, chronic rotator cuff tears, arthroscopic repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Infusion of Aclasta®Drug
Intravenous Infusion of Aclasta® (Verum) or physiological saline solution 0.9% (Placebo)
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic Acid | Active comparator | zoledronic acid 5 mg (Aclasta®) administered as single intravenous infusion (100 ml): Verum Receives: 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 Receives: Drug: Intravenous Infusion of Aclasta® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon integrity of the rotator cuff by means of magnetic resonance imaging.
postoperative anatomically regular tendon thickness comparable to an intact tendon.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start22 Aug 2022
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OrthopedicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo controlled trial (Zoledronic acid versus Placebo), randomized, 2 Teams: unblinded and blinded
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AUVA Traumazentrum Vienna Site UKH Meidling
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
- Responsible party
- Principal investigator, Jakob Schanda, AUVA Trauma Center Meidling
- Investigators
- Jakob Schanda, DDr., Principal investigator, AUVA Traumazentrum Vienna Site UKH Meidling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677152
- Sponsor's protocol ID
- ZORRO
- Acronym
- ZORRO
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Aug;54(10):2516-2526. doi: 10.1177/03635465261455031. Epub 2026 Jun 18.
PubMed 42316896Schanda 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.
PubMed 41549490
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT05677152
- Acronym / sponsor ID
- ZORRO / ZORRO
- Conditions
- Orthopedics, Traumatology
- Keywords
- zoledronic acid, chronic rotator cuff tears, arthroscopic repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AUVA Traumazentrum Vienna Site UKH MeidlingUniversity, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- placebo controlled trial (Zoledronic acid versus Placebo), randomized, 2 Teams: unblinded and blinded
| Arm | Type | Receives |
|---|---|---|
| Zoledronic Acid | Active comparator | Drug: Intravenous Infusion of Aclasta®zoledronic acid 5 mg (Aclasta®) administered as single intravenous infusion (100 ml): Verum |
| physiological saline solution 0.9% | Placebo comparator | Drug: Intravenous Infusion of Aclasta®Sodium chloride (physiological saline solution 0.9%) administered as single intravenous infusion (100 ml): Placebo |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Infusion of Aclasta®Intravenous Infusion of Aclasta® (Verum) or physiological saline solution 0.9% (Placebo) | Drug | Zoledronic Acid, physiological saline solution 0.9% |
Primary outcome
Tendon integrity of the rotator cuff by means of magnetic resonance imaging.
Time frame: 8 years
postoperative anatomically regular tendon thickness comparable to an intact tendon.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 42316896Schanda 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 Aug;54(10):2516-2526. doi: 10.1177/03635465261455031. Epub 2026 Jun 18.
- Derived from this study: PubMed 41549490Schanda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob Schanda, DDr. principal investigator
AUVA Traumazentrum Vienna Site UKH Meidling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous Infusion of Aclasta® in people with Orthopedics and Traumatology, run by AUVA Traumazentrum Vienna Site UKH Meidling at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendon integrity of the rotator cuff by means of magnetic resonance imaging. (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677152, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.