Study on Structum® in Adult Patients with Osteoarthritis (TRUST)
- Conditions
- Osteoarthritis, Knee
- Registration Number
- NCT06623773
- Lead Sponsor
- Pierre Fabre Medicament
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
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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:
- 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.
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Patients who have been prescribed, for the first time or not, Structum®.
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If patient is taking any NSAIDs or other analgesics, patient could be on stable dose at least one week before inclusion to the study.
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Patients able to visit the clinic and attend follow-up visits.
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Patients having signed an informed consent form, according to local regulations.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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®. baseline 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.
- Secondary Outcome Measures
Name Time Method Secondary Womac outcomes at 3-months from baseline to 3 months after baseline Mean difference in symptoms severity score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC )Questionnaire.
Secondary Womac outcomes at 6-months from baseline to 6 months after baseline 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.Bone's outcome at baseline 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.
Bone's outcome at 3 months from baseline to 3 months after baseline 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
Bone's outcome at 6 months from baseline to 6 months after baseline 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
SF12 outcome at baseline 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.
SF12 outcome at 3 months from baseline to 3 months after 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
SF12 outcome at 6 months from baseline to 6 months after 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.
SF12 outcome at baseline at 6 months from baseline to 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
Persitence outcomes at 3 months from baseline to 3 months after baseline proportion of patients with ongoing Structum® at 3 months
Persitence outcomes at 6 months from baseline to 6 months after baseline proportion of patients with ongoing Structum® at 6 months
Personal global assessment, after first dose of Structum®, at 3 months from baseline to 3 months after baseline Proportion of patients with a positive assessment of Structum®, as assessed by Structum® treatment satisfaction questionnaire
Personal global assessment, after first dose of Structum®, at 6 months from baseline to 6 months after baseline Proportion of patients with a positive assessment of Structum®, as assessed by Structum® treatment satisfaction questionnaire
Trial Locations
- Locations (15)
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
🇵🇱Warszawa, Poland
Mariusz Borowiecki
🇵🇱Zielona Gora, Poland
Michał Straburzyński
🇵🇱Zielona Góra, Poland
Viktor Kostiuk
🇵🇱Żagań, Poland