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

NCT06623773 | Completed

• 1 other identifier: NIS13559
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 15

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• describe the baseline clinical profile and baseline OA symptom severity (pain, stiffness and function) as assessed by the (WOMAC) questionnaire, for patients with knee OA and treated with Structum®.

  description at enrollment of Demographics and clinical characteristics of patients with knee OA- description of treatment history- description of knee OA symptm severity per the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC )Questionnaire. The total WOMAC score range is from 0-2400, with higher scores indicating worse pain, stiffness, and functional limitations.

  baseline

Secondary Outcomes (24)

• Secondary Womac outcomes at 3-months

  from baseline to 3 months after baseline

• Secondary Womac outcomes at 3-months

  from baseline to 3 months after baseline

• Secondary Womac outcomes at 3-months

  from baseline to 3 months after baseline

• Secondary Womac outcomes at 6-months

  from baseline to 6 months after baseline

• Secondary Womac outcomes at 6-months

  from baseline to 6 months after baseline

Other Outcomes (10)

• Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the SF-12 questionnaire at inclusion.

  baseline

• Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the SF-12 questionnaire at 3 months

  from baseline to 3 months after baseline

• Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the SF-12 questionnaire at 6 months

  from baseline to 6 months after baseline

Interventions

Chondroitin sulfate DRUG

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.

Also known as: Structum

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients aged 50 to 80 years with a confirmed diagnosis of knee osteoarthritis and a new prescription for Structum®, as treated by participating centers in Poland.

You may qualify if:

• knee pain lasting for at least 3 months;
• knee radiographs showing knee joint narrowing and/or osteophytes.
• Patients who have been prescribed, for the first time or not, Structum®.
• Patients able to visit the clinic and attend follow-up visits.
• Patients having signed an informed consent form, according to local regulations.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (15)

Maciej Dołżyński

Bialystok, 15-481, Poland

Location

Piotr Ligocki

Bydgoszcz, 85-091, Poland

Location

Elżbieta Pietrus- Dunaszewska

Katowice, 40-007, Poland

Location

Bartlomiej Szpyra

Krakow, 31-155, Poland

Location

Alina Wołkowicz Mruk

Krakow, 31-455, Poland

Location

Andrzej Majer

Kujakowice Gorn, 46-211, Poland

Location

Agnieska WIAK

Lubartów, 21-100, Poland

Location

Wojciech Larczyński

Nowy Dwór Gdański, 82-100, Poland

Location

Sławomir Panek

Olesno, 46-300, Poland

Location

Marcin Milchert

Szczecin, 71-497, Poland

Location

Wojciech Roczniak

Ustrzyki Dolne, Ustrzyki Dolne, Poland

Location

Zdzisław Derleta

Warsaw, 03-938, Poland

Location

Michał Straburzyński

Zielona Góra, 65-047, Poland

Location

Mariusz Borowiecki

Zielona Góra, 65-559, Poland

Location

Viktor Kostiuk

Żagań, 68-100, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Chondroitin Sulfates

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chondroitin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• PIOTR WILAND

  Medical University of WROCLAW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: October 2, 2024
• Study Start: June 27, 2023
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (15)