Clinical trial NCT06623773: Study on Structum® in Adult Patients with Osteoarthritis (TRUST)
Official title: Prospective Non-Interventional Study on Structum® in Adult Patients with Osteoarthritis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis, Knee
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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®.
timeFrame: baseline
Secondary outcomes:
measure: Secondary Womac outcomes at 3-months
timeFrame: from baseline to 3 months after baseline
measure: Secondary Womac outcomes at 3-months
timeFrame: from baseline to 3 months after baseline
measure: Secondary Womac outcomes at 3-months
timeFrame: from baseline to 3 months after baseline
measure: Secondary Womac outcomes at 6-months
timeFrame: from baseline to 6 months after baseline
measure: Secondary Womac outcomes at 6-months
timeFrame: from baseline to 6 months after baseline
measure: Secondary Womac outcomes at 6-months
timeFrame: from baseline to 6 months after baseline
measure: Bone's outcome at baseline
timeFrame: baseline
measure: Bone's outcome at baseline
timeFrame: baseline
measure: Bone's outcome at 3 months
timeFrame: from baseline to 3 months after baseline
measure: Bone's outcome at 6 months
timeFrame: from baseline to 6months after baseline
measure: Bone's outcome at 3 months
timeFrame: from baseline to 3 months after baseline
measure: Bone's outcome at 6 months
timeFrame: from baseline to 6 months after baseline
measure: Bone's outcome at 3 months
timeFrame: from baseline to 3 months after baseline
measure: Bone's outcome at 6 months
timeFrame: from baseline to 6 months after baseline
measure: SF12 outcome at baseline
timeFrame: baseline
measure: SF12 outcome at 3 months
timeFrame: from baseline to 3 months after baseline
measure: SF12 outcome at 6 months
timeFrame: from baseline to 6 months after baseline
measure: SF12 outcome at baseline
timeFrame: baseline
measure: SF12 outcome at 3 months
timeFrame: from baseline to 3 months after baseline
measure: SF12 outcome at baseline at 6 months
timeFrame: from baseline to 6 months
measure: Persitence outcomes at 3 months
timeFrame: from baseline to 3 months after baseline
measure: Persitence outcomes at 6 months
timeFrame: from baseline to 6 months after baseline
measure: Personal global assessment, after first dose of Structum®, at 3 months
timeFrame: from baseline to 3 months after baseline
measure: Personal global assessment, after first dose of Structum®, at 6 months
timeFrame: from baseline to 6 months after baseline
Other outcomes:
measure: Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the SF-12 questionnaire at inclusion.
timeFrame: baseline
measure: Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the SF-12 questionnaire at 3 months
timeFrame: from baseline to 3 months after baseline
measure: Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the SF-12 questionnaire at 6 months
timeFrame: from baseline to 6 months after baseline
measure: Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the WOMAC questionnaire at inclusion
timeFrame: baseline
measure: Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the WOMAC questionnaire at 3 months
timeFrame: from baseline to 3 months after baseline
measure: Spearman correlation coefficient and P value for the correlation between the BONe'S questionnaire and the WOMAC questionnaire at 6 months.
timeFrame: from baseline to 6 months after baseline
measure: Variables of interest for the assessment of this exploratory outcome will originate from the BONe'S, SF-12 and WOMAC questionnaires
timeFrame: from baseline to 6 months after baseline
measure: Proportion of patients with changes in the prescription of NSAIDs and other analgesics 6 months before inclusion, at inclusion
timeFrame: baseline
measure: Proportion of patients with changes in the prescription of NSAIDs and other analgesics 6 months before inclusion, at 3 months
timeFrame: from baseline to 3 months after baseline
measure: Proportion of patients with changes in the prescription of NSAIDs and other analgesics 6 months before inclusion, at 6 months
timeFrame: from baseline to 6 months after baseline
Locations:
city: Bialystok
country: Poland
facility: Maciej Dołżyński
city: Bydgoszcz
country: Poland
facility: Piotr Ligocki
city: Katowice
country: Poland
facility: Elżbieta Pietrus- Dunaszewska
city: Krakow
country: Poland
facility: Bartlomiej Szpyra
city: Krakow
country: Poland
facility: Alina Wołkowicz Mruk
city: Kujakowice Gorn
country: Poland
facility: Andrzej Majer
city: Lubartów
country: Poland
facility: Agnieska WIAK
city: Nowy Dwór Gdański
country: Poland
facility: Wojciech Larczyński
city: Olesno
country: Poland
facility: Sławomir Panek
city: Szczecin
country: Poland
facility: Marcin Milchert
city: Ustrzyki Dolne
country: Poland
facility: Wojciech Roczniak
city: Warszawa
country: Poland
facility: Zdzisław Derleta
city: Zielona Gora
country: Poland
facility: Mariusz Borowiecki
city: Zielona Góra
country: Poland
facility: Michał Straburzyński
city: Żagań
country: Poland
facility: Viktor Kostiuk
Study officials:
affiliation: Medical University of WROCLAW
name: PIOTR WILAND
role: PRINCIPAL_INVESTIGATOR
References: