E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
INFLUENCE OF ZOLEDRONIC ACID ON HEALING AFTER ARTHROSCOPIC REPAIR OF CHRONIC ROTATOR CUFF LESIONS |
EINFLUSS VON ZOLEDRONSÄURE AUF DIE HEILUNG NACH ARTHROSKOPISCHER REPARATUR CHRONISCHER ROTATORENMANSCHETTENLÄSIONEN
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E.1.1.1 | Medical condition in easily understood language |
Influence of zoledronic acid on healing after surgery from a tearing of tendons and muscles in the shoulder |
Einfluss von Zoledronsäure auf die Heilung nach einer Operation von einem Abriss von sehnen und Muskeln in der Schulter |
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E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the influence of an adjuvant, intravenous therapy with zoledronic acid (single dose) on healing after arthroscopic repair of chronic rotator cuff tears. |
Beurteilung des Einflusses einer adjuvanten, intravenösen Therapie mit Zoledronsäure (Einzeldosis) auf die Heilung nach arthroskopischer Reparatur von chronischen Rotatorenmanschettenrissen. |
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E.2.2 | Secondary objectives of the trial |
not applicable |
nicht zutreffe |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age between 50 and 70 years • Magnetic resonance imaging verified rotator cuff tear (done within 6 month before 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
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• Alter zwischen 50 und 70 Jahren • Magnetresonanztomographie verifizierter Rotatorenmanschettenriss (binnen 6 Monaten vor OP durchgeführt) • Bruchgröße mit einem maximalen Durchmesser von 3 cm • Bereitschaft zur Teilnahme an der Studie • Bereitschaft zur Teilnahme an einer einheitlichen Physiotherapie mit Verwendung eines Schulterabduktionspolsters für vier Wochen postoperativ
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E.4 | Principal 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 ≥ 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
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• Patienten unter 50 Jahren oder älter als 70 Jahre • Schwangerschaft • Bekannte Allergie gegen Zoledronsäure oder andere Bestandteile des Arzneimittels • Vorherige Fraktur der betroffenen Schulter • Vorherige Operation der betroffenen Schulter • Frühere oder bestehende bakterielle Infektion der betroffenen Schulter •• Ruptur von mehr als zwei Sehnen in der betroffenen Schulter (massiver Rotatorenmanschettenriss) • Isolierter Subscapularissehnenriss • Vorhandensein von glenohumeraler Osteoarthritis (Hamada Typ 3 oder höher) • Diabetes mellitus (Nüchternglukose ≥ 126 mg/dl, HbA1C ≥ 6,5%)• Bösartige Tumorerkrankung • Pathologischer Zahnstatus • Bekannte Krankheit, die den Knochenstoffwechsel stört • Begleiterkrankungen, die keine Vollnarkose zulassen • Vorherige Therapie mit antiosteoporotischen Medikamenten (Bisphosphonate, Denosumab, Teriparatid) - Epilepsie • Klaustrophobie • Chronischer Alkoholmissbrauch • Drogenmissbrauch |
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E.5 End points |
E.5.1 | Primary end point(s) |
investigation of zoledronic acid on tendon integrity via magnetic resonance imaging at six months and at twelve months after arthroscopic repair of chronic rotator cuff lesions. |
Untersuchung der Zoledronsäure auf die Sehnenintegrität mittels Magnetresonanztomographie nach sechs Monaten und nach zwölf Monaten nach arthroskopischer Reparatur chronischer Rotatorenmanschettenläsionen.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
six months and at twelve months after arthroscopic repair of chronic rotator cuff lesions. |
3 und 6 Monate nach Operation der gerissenen Rotatorenmanschette |
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E.5.2 | Secondary end point(s) |
Examination of bone metabolism, micro-RNA , specific clinical test concerning shoulder function as well as collection of functional questionaires to investigate the muscular regeneration by zoledronic acid |
Untersuchung des Knochenstoffwechsels, micro-RNA, spezifischer klinischer Test zur Schulterfunktion sowie Sammlung funktioneller Fragebögen zur Untersuchung der Muskelregeneration durch Zoledronsäure |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 day, 4 week, 3 month, 6 month and 12 month after arthroscopic repair of chronic rotator cuff lesions. |
2 Tage, 4 Wochen, 3 Monate, 6 Monate und 12 Monate nach arthroskopischer Reparatur von chronischen Rotatorenmanschettenläsionen. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
last visit of last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |