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

Prospective Non-Interventional Study on Structum® in Adult Patients With Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Chondroitin sulfate

Detailed Description

This is an observational, descriptive, national, multicentric (11 centres), 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.

• Study Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• Poland
  • Bialystok, Poland, 15-481
    • Maciej Dołżyński
  • Bydgoszcz, Poland, 85-091
    • Piotr Ligocki
  • Katowice, Poland, 40-007
    • Elżbieta Pietrus- Dunaszewska
  • Krakow, Poland, 31-155
    • Bartlomiej Szpyra
  • Krakow, Poland, 31-455
    • Alina Wołkowicz Mruk
  • Kujakowice Gorn, Poland, 46-211
    • Andrzej Majer
  • Lubartów, Poland, 21-100
    • Agnieska WIAK
  • Nowy Dwór Gdański, Poland, 82-100
    • Wojciech Larczyński
  • Olesno, Poland, 46-300
    • Sławomir Panek
  • Szczecin, Poland, 71-497
    • Marcin Milchert
  • Ustrzyki Dolne, Poland, Ustrzyki Dolne
    • Wojciech Roczniak
  • Warsaw, Poland, 03-938
    • Zdzisław Derleta
  • Zielona Góra, Poland, 65-047
    • Michał Straburzyński
  • Zielona Góra, Poland, 65-559
    • Mariusz Borowiecki
  • Żagań, Poland, 68-100
    • Viktor Kostiuk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients aged 50 to 85 years with a confirmed diagnosis of knee osteoarthritis and a new prescription for Structum®, as treated by participating centers in Poland.

Description

Inclusion Criteria:

• Male or female patients aged 50 to 85 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®.
• patient taking any non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics should 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteoarthritis (OA) Symptom Severity (Pain, Stiffness and Function) as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire, for Patients With Knee OA and Treated With Structum®, at Baseline	Description of knee OA symptom 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.	At baseline (inclusion)
Charlson Comorbidity Index Score Measured at Baseline	The Charlson Comorbidity Index (CCI) is a scoring system used to predict mortality risk in patients with multiple comorbidities. The index evaluates 17 conditions, with each condition assigned a score based on its severity and the risk of mortality associated with it. The score is rated from 0 to 37. A higher score indicates a higher number of comorbidities.	At baseline (inclusion)
Treatment History Received by the Patients in the Past 6 Months Before Inclusion	Treatment history corresponds to the treatment received or not (yes/no) for knee osteoarthritis in the past 6 months before inclusion in the study	From 6 months before inclusion to inclusion (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 3 Months	Total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire. Total score at 3 months and mean difference from baseline to 3 months are provided. The total WOMAC score range is from 0-2400, with higher scores indicating worse pain, stiffness and functional limitations.	From baseline (inclusion) to 3 months after baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 6-months	Total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire. Total score at 6 months and mean difference from baseline to 6 months are provided. The total WOMAC score range is from 0-2400, with higher scores indicating worse pain, stiffness, and functional limitations.	From baseline to 6 months after baseline
BONe's Questionnaire at Baseline	Mean global score of the osteoarthritis burden of the Burden Osteoarthritis New'Scale (BONe'S). The total score range is 0-100 scale. Higher scores represent a heavier burden.	At baseline (inclusion)
BONe's Outcome at 3 Months	Mean global score of the OA burden of the Burden Osteoarthritis New'Scale (BONe'S).The total score range is 0-100 scale. Higher scores represent a heavier burden. Global score at 3 months and mean difference from baseline to 3 months are provided.	From baseline (inclusion) to 3 months after baseline
BONe's Outcome at 6 Months	Mean global score of the OA burden of the Burden Osteoarthritis New'Scale (BONe'S). The total score range is 0-100 scale. Higher scores represent a heavier burden. The Global score at 6 months and the mean difference from baseline to 6 months are provided.	From baseline (inclusion) to 6 months after baseline
Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at Baseline	Global score of general health (physical score component) of the Short Form Questionnaire with 12 questions (SF-12) Scores range from 0 to 100, with higher scores indicating a better physical functioning.	At baseline (inclusion)
Short Form Questionnaire With 12 Questions (SF-12) Outcome: Physical Score Component at 3 Months	Global score of general health (physical score component) of the Short Form Questionnaire with 12 questions (SF-12). Scores range from 0 to 100, with higher scores indicating better physical functioning. Global score at 3 months and mean difference from baseline to 3 months are provided.	From baseline to 3 months after baseline
Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at 6 Months	Global score of general health (physical score component) of the Short Form Questionnaire with 12 questions (SF-12). Scores range from 0 to 100, with higher scores indicating better physical functioning. Global score at 6 months and mean difference from baseline to 6 months are provided	From baseline to 6 months after baseline
Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at Baseline	Global score of mental score component of the Short Form Questionnaire with 12 questions (SF-12). Scores range from 0 to 100, with higher scores indicating a better mental health functioning.	Baseline
Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at 3 Months	Global score (mental score component) of the Short Form Questionnaire with 12 questions (SF-12). Scores range from 0 to 100, with higher scores indicating a better mental health functioning. Global score at 3 months and mean difference from baseline to 3 months are provided.	From baseline to 3 months after baseline
Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at 6 Months	Global score (mental score component) of the Short Form Questionnaire with 12 questions (SF-12). Scores range from 0 to 100, with higher scores indicating a better mental health functionning. Global score at 6 months and mean difference from baseline to 6 months are provided.	From baseline to 6 months
Persistence Outcomes at 3 Months	Proportion of patients with ongoing Structum® prescription at 3 months	At 3 months after baseline
Persistence Outcomes at 6 Months	Proportion of patients with ongoing Structum® prescription at 6 months	At 6 months after baseline
Global Score of Patients Satisfaction, After First Dose of Structum®, at 3 Months	Global statisfaction score of patient at 3 months, as assessed by Structum® treatment satisfaction questionnaire. The Global satisfaction score ranges from 0 to 100. A higher score indicates a higher satisfaction.	At 3 months after baseline
Global Score of Patient Satisfaction, After First Dose of Structum®, at 6 Months	Global satisfaction score of patient at 6 months, as assessed by Structum® treatment satisfaction questionnaire. The Global satisfaction score range from 0 to 100. A higher score indicates a higher satisfaction.	At 6 months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the Short Form Questionnaire, SF-12 Questionnaire (Physical and Mental Component) at Inclusion.	The interpretation of the correlation coefficient is as follows: <0.5: weak correlation 0.5-0.6: mild correlation 0.6-0.7: moderate correlation >0.7: strong correlation Of note, values of the coefficient could be positive or negative	Baseline (inclusion)
Spearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the SF-12 Questionnaire (Physical and Mental Components) at 3 Months		At 3 months after baseline
Spearman Correlation Coefficient for the Correlation Between the BONe'S Questionnaire and the Short Form, SF-12 Questionnaire at 6 Months.	The interpretation of the correlation coefficient is as follows: <0.5: weak correlation 0.5-0.6: mild correlation 0.6-0.7: moderate correlation >0.7: strong correlation	At 6 months after baseline
Spearman Correlation Coefficient for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at Inclusion	The interpretation of the correlation coefficient is as follows: <0.5: weak correlation 0.5-0.6: mild correlation 0.6-0.7: moderate correlation >0.7: strong correlation	Baseline (inclusion)
Spearman Correlation Coefficient and P Value for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at 3 Months	The interpretation of the correlation coefficient is as follows: <0.5: weak correlation 0.5-0.6: mild correlation 0.6-0.7: moderate correlation >0.7: strong correlation	At 3 months after baseline
Spearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at 6 Months.	The interpretation of the correlation coefficient is as follows: <0.5: weak correlation 0.5-0.6: mild correlation 0.6-0.7: moderate correlation >0.7: strong correlation	At 6 months after baseline
Change in NSAIDs and Other Analgesics at Inclusion Compared to 6 Months Before Inclusion	Description of the proportion of patients with a change in their prescription of NSAIDs and other analgesics at inclusion, compared to 6 months before inclusion, with a change being defined as any change of the daily dose of NSAIDs (calculated from the frequency of intake and the dose of each intake); Increased; Stable; Decreased	Baseline (inclusion)
Changes in NSAIDs and Other Analgesics at 3 Months Compared to Inclusion	Proportion of patients with changes in the prescription of NSAIDs and other analgesics at 3 months compared to inclusion	From baseline to 3 months after baseline
Change in NSAIDs and Other Analgesics at 6 Months Compared to Inclusion	Proportion of patients with changes in the prescription of NSAIDs and other analgesics at 6 months compared to inclusion	From baseline to 6 months after baseline

Collaborators and Investigators

• Sponsor: Pierre Fabre Medicament
• Investigators: Principal Investigator: PIOTR WILAND, Medical University of WROCLAW

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Actual): October 28, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Carbohydrates; Glycosaminoglycans; Polysaccharides; Chondroitin; Chondroitin Sulfates
• Other Study ID Numbers: NIS13559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Data will be collected and retained in a pseudonymized format, with no directly identifying values that might link the data to the corresponding participant to the study.

The Investigator must ensure that the patient's confidentiality is maintained. It is required that the Investigator and institution permit authorized representatives of the Sponsor, of the regulatory agency(s), and the institutional ECs direct access to review the patient's original medical records for verification of study-related procedures and data. Direct access includes examining, analyzing, verifying, and reproducing any records and reports that are important to the evaluation of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No