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COMPLETED
NCT06623773

Study on Structum® in Adult Patients With Osteoarthritis (TRUST)

Sponsor: Pierre Fabre Medicament

View on ClinicalTrials.gov

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

Interventions

DRUG

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