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

NCT ID: NCT06623773

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 151 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-27
• Study Completion Date: 2024-10-28

Brief Summary

Chondroitin sulfate (CS) is a 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 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.

Detailed Description

This is an observational, descriptive, national, multicentric, prospective, longitudinal study, which will be conducted over a 6-month follow-up period for each patient. The study will not provide or recommend any specific treatment or procedures.

All patients affected by OA in the knee, for whom Structum® is prescribed in a participating center, will be screened in a consecutive manner for eligibility. The study will focus exclusively on patients with OA in the knee as this is the joint most frequently affected and most easily assessed for OA patients.

Two additional data collections can be anticipated for these patients as part of their standard of care follow-up visits, which will usually occur around 3 and 6 months after the initial study visit.The patient enrolment period is expected to be 6 months, with a total study duration of 12 months.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

Intervention Type: DRUG

Other Intervention Names

Structum

Eligibility Criteria

Inclusion Criteria

• Male or female patients aged 50 to 80 years at inclusion
• of knee OA (either a patient newly diagnosed [at inclusion] or with history of knee OA) based on at least the following items 1 and/or 2:

1. knee pain lasting for at least 3 months;

2. patient in the active phase of knee OA disease (knee pain score ≥ 40mm at inclusion on the Visual Analog Scale [VAS] 0-100 mm);

3. knee radiographs showing knee joint narrowing and/or osteophytes.

• Patients who have been prescribed, for the first time or not, Structum®.
• If patient is taking any NSAIDs or other analgesics, patient could be on stable dose at least one week before inclusion to the study.
• Patients able to visit the clinic and attend follow-up visits.
• Patients having signed an informed consent form, according to local regulations.

Exclusion Criteria

• Patients with any ongoing chondroitin sulfate treatment at inclusion or during the last 3 months.
• plasma (in the last 3 months). No glucocorticoids administration in the last 3 months before inclusion. That does not include NSAIDS, paracetamol and other analgesic medications (e.g. tramadol).
• Patients with an artificial knee joint, including unilateral.
• Patients scheduled to undergo knee replacement surgery in the next 6 months.
• Patients with a severe general condition that prevents them from being included in the study as assessed by the investigator.
• Patients participating in interventional trials on investigational drugs at the time of inclusion.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Medicament

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PIOTR WILAND

Role: PRINCIPAL_INVESTIGATOR

Medical University of WROCLAW

Locations

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

Countries

Poland

Other Identifiers

NIS13559

Identifier Type: -

Identifier Source: org_study_id