Osteoarthritis, KneeTRUSTNCT06623773
Study on Structum® in Adult Patients With Osteoarthritis (TRUST)
An observational study of Osteoarthritis, Knee, run by Pierre Fabre Medicament at 15 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Chondroitin sulfate
- Type of treatment
- Pill or oral medicine
- How many people
- 136 participants
- Where
- 15 sitesPoland
- Study dates
- 12 Jul 2023to 28 Oct 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- knee pain lasting for at least 3 months;
- patient in the active phase of knee OA disease (knee pain score ≥ 40mm at inclusion on the Visual Analog Scale [VAS] 0-100 mm);
- knee radiographs showing knee joint narrowing and/or osteophytes.
- Patients who have been prescribed, for the first time or not, Structum®.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Poland15 sites
Maciej Dołżyński
Bialystok, 15-481
Piotr Ligocki
Bydgoszcz, 85-091
Elżbieta Pietrus- Dunaszewska
Katowice, 40-007
Bartlomiej Szpyra
Krakow, 31-155
Alina Wołkowicz Mruk
Krakow, 31-455
Andrzej Majer
Kujakowice Gorn, 46-211
Agnieska WIAK
Lubartów, 21-100
Wojciech Larczyński
Nowy Dwór Gdański, 82-100
Sławomir Panek
Olesno, 46-300
Marcin Milchert
Szczecin, 71-497
Wojciech Roczniak
Ustrzyki Dolne, Ustrzyki Dolne
Zdzisław Derleta
Warsaw, 03-938
Viktor Kostiuk
Żagań, 68-100
Michał Straburzyński
Zielona Góra, 65-047
Mariusz Borowiecki
Zielona Góra, 65-559
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Chondroitin sulfate
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin sulfateDrug
Also called Structum
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: From 6 months before inclusion to inclusion (baseline)
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 6 months
Persistence Outcomes at 3 Months
Proportion of patients with ongoing Structum® prescription at 3 months
Measured: At 3 months after baseline
Persistence Outcomes at 6 Months
Proportion of patients with ongoing Structum® prescription at 6 months
Measured: 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.
Measured: 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.
Measured: At 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start12 Jul 2023
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PIOTR WILAND, Principal investigator, Medical University of WROCLAW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623773
- Sponsor's protocol ID
- NIS13559
- Acronym
- TRUST
- Status last verified
- Jul 2026
- First submitted
- 15 Mar 2024
- Last updated
- 8 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-Interventional Study on Structum® in Adult Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT06623773
- Acronym / sponsor ID
- TRUST / NIS13559
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 2 Oct 2024 (actual)
- Results
- Posted 8 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chondroitin sulfateAlso: StructumChondroitin 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. | Drug | – |
Primary outcome
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
Time frame: At baseline (inclusion)
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.
Charlson Comorbidity Index Score Measured at Baseline
Time frame: At baseline (inclusion)
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.
Treatment History Received by the Patients in the Past 6 Months Before Inclusion
Time frame: From 6 months before inclusion to inclusion (baseline)
Treatment history corresponds to the treatment received or not (yes/no) for knee osteoarthritis in the past 6 months before inclusion in the study
15 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 3 Months
Time frame: From baseline (inclusion) to 3 months after baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 6-months
Time frame: From baseline to 6 months after baseline
BONe's Questionnaire at Baseline
Time frame: At baseline (inclusion)
BONe's Outcome at 3 Months
Time frame: From baseline (inclusion) to 3 months after baseline
BONe's Outcome at 6 Months
Time frame: From baseline (inclusion) to 6 months after baseline
Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at Baseline
Time frame: At baseline (inclusion)
Short Form Questionnaire With 12 Questions (SF-12) Outcome: Physical Score Component at 3 Months
Time frame: From baseline to 3 months after baseline
Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at 6 Months
Time frame: From baseline to 6 months after baseline
Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at Baseline
Time frame: Baseline
Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at 3 Months
Time frame: From baseline to 3 months after baseline
Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at 6 Months
Time frame: From baseline to 6 months
Persistence Outcomes at 3 Months
Time frame: At 3 months after baseline
Persistence Outcomes at 6 Months
Time frame: At 6 months after baseline
Global Score of Patients Satisfaction, After First Dose of Structum®, at 3 Months
Time frame: At 3 months after baseline
Global Score of Patient Satisfaction, After First Dose of Structum®, at 6 Months
Time frame: At 6 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PIOTR WILAND principal investigator
Medical University of WROCLAW
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Pierre Fabre Medicament at 15 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At baseline (inclusion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.