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New treatment option for Orthopedics
Official title Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
ClinicalTrials.gov ID: NCT05677152
What this study is testing
What is Intravenous Infusion of Aclasta®?
Intravenous Infusion of Aclasta® is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for orthopedics.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 70
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.