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 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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 151

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
  • Warszawa, Poland, 03-938
    • Zdzisław Derleta
  • Zielona Gora, Poland, 65-559
    • Mariusz Borowiecki
  • Zielona Góra, Poland, 65-047
    • Michał Straburzyński
  • 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 80 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 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Womac outcomes at 3-months	Mean global score of symptoms severity of 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.	from baseline to 3 months after baseline
Secondary Womac outcomes at 3-months	Mean score of each dimension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC )Questionnaire. For each dimension, the values scored on each item will be summed to give a dimension score, with pain ranging from 0-500, stiffness 0-200, and physical function 0-1700.	from baseline to 3 months after baseline
Secondary Womac outcomes at 3-months	Mean difference in symptoms severity score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC )Questionnaire.	from baseline to 3 months after baseline
Secondary Womac outcomes at 6-months	Mean difference in symptoms severity score of 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.	from baseline to 6 months after baseline
Secondary Womac outcomes at 6-months	Mean score of each dimension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC )Questionnaire. For each dimension, the values scored on each item will be summed to give a dimension score, with pain ranging from 0-500, stiffness 0-200, and physical function 0-1700.	from baseline to 6 months after baseline
Secondary Womac outcomes at 6-months	Mean global score of symptom severity of 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.	from baseline to 6 months after baseline
Bone's outcome at baseline	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	baseline
Bone's outcome at baseline	Mean score of each dimension of the Burden Osteoarthritis New'Scale (BONe'S) Each question (19 questions) of each dimension is evaluated from to 5.	baseline
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	from baseline 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	from baseline to 6months after baseline
Bone's outcome at 3 months	Mean score of each dimension of the Burden Osteoarthritis New'Scale (BONe'S) Each question (19 questions) of each dimension is evaluated from to 5.	from baseline to 3 months after baseline
Bone's outcome at 6 months	Mean score of each dimension of the Burden Osteoarthritis New'Scale (BONe'S) The total score range is 0-100 scale. Higher scores represent a heavier burden	from baseline to 6 months after baseline
Bone's outcome at 3 months	Mean difference in OA burden scores at 3 months of the Burden Osteoarthritis New'Scale (BONe'S) The total score range is 0-100 scale. Higher scores represent a heavier burden	from baseline to 3 months after baseline
Bone's outcome at 6 months	Mean difference in OA burden scores at 6 months of the Burden Osteoarthritis New'Scale (BONe'S) The total score range is 0-100 scale. Higher scores represent a heavier burden	from baseline to 6 months after baseline
SF12 outcome at baseline	mean global score of general health of the Short Form Questionnaire (SF12) Scores range from 0 to 100, with higher scores indicating a better physical and mental health functioning.	baseline
SF12 outcome at 3 months	mean global score of general health of the Short Form Questionnaire (SF12) Scores range from 0 to 100, with higher scores indicating a better physical and mental health functioning.	from baseline to 3 months after baseline
SF12 outcome at 6 months	mean global score of general health of the Short Form Questionnaire (SF12) Scores range from 0 to 100, with higher scores indicating a better physical and mental health functioning.	from baseline to 6 months after baseline
SF12 outcome at baseline	mean score of physical and mental dimension of the Short Form Questionnaire (SF12) A special scoring program, accessible via the license purchase of the questionnaire, will be used to analyze this questionnaire by giving a ponderation to each item to result in two different dimension scores.	baseline
SF12 outcome at 3 months	mean score of physical and mental dimension of the Short Form Questionnaire (SF12) A special scoring program, accessible via the license purchase of the questionnaire, will be used to analyze this questionnaire by giving a ponderation to each item to result in two different dimension scores	from baseline to 3 months after baseline
SF12 outcome at baseline at 6 months	mean score of physical and mental dimension of the Short Form Questionnaire (SF12) A special scoring program, accessible via the license purchase of the questionnaire, will be used to analyze this questionnaire by giving a ponderation to each item to result in two different dimension scores	from baseline to 6 months
Persitence outcomes at 3 months	proportion of patients with ongoing Structum® at 3 months	from baseline to 3 months after baseline
Persitence outcomes at 6 months	proportion of patients with ongoing Structum® at 6 months	from baseline to 6 months after baseline
Personal global assessment, after first dose of Structum®, at 3 months	Proportion of patients with a positive assessment of Structum®, as assessed by Structum® treatment satisfaction questionnaire	from baseline to 3 months after baseline
Personal global assessment, after first dose of Structum®, at 6 months	Proportion of patients with a positive assessment of Structum®, as assessed by Structum® treatment satisfaction questionnaire	from baseline to 6 months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the WOMAC questionnaire at inclusion		baseline
Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the WOMAC 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 WOMAC questionnaire at 6 months.		from baseline to 6 months after baseline
Variables of interest for the assessment of this exploratory outcome will originate from the BONe'S, SF-12 and WOMAC questionnaires	Calculation of the Spearman correlation coefficient at inclusion, 3, and 6 months for the correlation between; the BONe'S questionnaire (the independence + interaction & recreation + hygiene & beauty scores) and the SF-12 questionnaire (physical component summary dimension).; the BONe'S questionnaire (psychological score) and the SF-12 questionnaire (mental component summary dimension); the global score of the BONe'S questionnaire and the total WOMAC score.	from baseline to 6 months after baseline
Proportion of patients with changes in the prescription of NSAIDs and other analgesics 6 months before inclusion, at inclusion	Description of the proportion of patients with a change in their prescription of NSAIDs and other analgesics 6 months before inclusion, at inclusion, and at 3 and 6 months, 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
Proportion of patients with changes in the prescription of NSAIDs and other analgesics 6 months before inclusion, at 3 months		from baseline to 3 months after baseline
Proportion of patients with changes in the prescription of NSAIDs and other analgesics 6 months before inclusion, at 6 months		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): June 27, 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): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• 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