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Study on Structum® in Adult Patients With Osteoarthritis (TRUST)
Sponsor: Pierre Fabre Medicament
Summary
Chondroitin sulfate (CS) is a Symptomatic Slow Acting Drugs for OsteoArthritis (SYSADOA) and a natural biomacromolecule belonging to the class of glycosaminoglycans. CS is a major component of the extracellular matrix (ECM), where it constitutes an essential component of proteoglycans. To this date, no real-world studies have been conducted to precisely describe the burden associated with osteoarthritis (OA) among patients treated with CS.Therefore, an observational, descriptive, prospective, national study will be conducted to describe the burden associated with OA and the quality of life of patients treated with Structum® in Poland.
Official title: Prospective Non-Interventional Study on Structum® in Adult Patients With Osteoarthritis
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
OBSERVATIONAL
Enrollment
136
Start Date
2023-07-12
Completion Date
2024-10-28
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
Chondroitin sulfate
Chondroitin sulfate (CS) is a natural biomacromolecule belonging to the class of glycosaminoglycans and is an unbranched complex polysaccharide consisting of a repeating disaccharide structure of glucuronic acid and N-acetyl-D-glucosamine \[18\]. It is a major component of the extracellular matrix (ECM), where it constitutes an essential component of proteoglycans. Oral bioavailability of CS has been demonstrated \[19\], and its use for the treatment of OA has been established in animal models \[20\], as well as in clinical trials \[21, 22\]. CS, is available as a pharmaceutical grade drug (Structum®), meaning that the product is manufactured under Good Manufacturing Practices (GMP) conditions, and is in excess of 99% purity with no binders, fillers, excipients, dyes, or unknown substances. According to the Instructions for Use (IFU), the recommended posology for Structum® is 500 mg twice daily.
Locations (15)
Maciej Dołżyński
Bialystok, Poland
Piotr Ligocki
Bydgoszcz, Poland
Elżbieta Pietrus- Dunaszewska
Katowice, Poland
Bartlomiej Szpyra
Krakow, Poland
Alina Wołkowicz Mruk
Krakow, Poland
Andrzej Majer
Kujakowice Gorn, Poland
Agnieska WIAK
Lubartów, Poland
Wojciech Larczyński
Nowy Dwór Gdański, Poland
Sławomir Panek
Olesno, Poland
Marcin Milchert
Szczecin, Poland
Wojciech Roczniak
Ustrzyki Dolne, Poland
Zdzisław Derleta
Warsaw, Poland
Michał Straburzyński
Zielona Góra, Poland
Mariusz Borowiecki
Zielona Góra, Poland
Viktor Kostiuk
Żagań, Poland