Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff L… (NCT05677152) | Clinical Trial Compass
RecruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Austria80 participantsStarted 2022-08-22
Plain-language 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.,
Who can participate
Age range
50 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tendon integrity of the rotator cuff by means of magnetic resonance imaging.
Timeframe: 8 years
Trial details
NCT IDNCT05677152
SponsorAUVA Traumazentrum Vienna Site UKH Meidling