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CompletedNCT06623773TRUSTUpdated Sep 8, 2026Results posted

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

An observational study in Osteoarthritis, Knee, sponsored by Pierre Fabre Medicament. Completed at 15 sites in Poland. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Pierre Fabre Medicament · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
136
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 136 is above the median of 100 across 472 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Pierre Fabre Medicament is the lead sponsor of 71 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
136 participants (actual)
Patient registry
No

Interventions

  • DrugChondroitin sulfate

    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.

    Also known as: Structum

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline (inclusion)

  2. 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.

    Time frame: At baseline (inclusion)

  3. 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

    Time frame: From 6 months before inclusion to inclusion (baseline)

Secondary outcomes

  1. 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.

    Time frame: From baseline (inclusion) to 3 months after baseline

  2. 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.

    Time frame: From baseline to 6 months after baseline

  3. 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.

    Time frame: At baseline (inclusion)

  4. 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.

    Time frame: From baseline (inclusion) to 3 months after baseline

  5. 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.

    Time frame: From baseline (inclusion) to 6 months after baseline

  6. 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.

    Time frame: At baseline (inclusion)

  7. 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.

    Time frame: From baseline to 3 months after baseline

  8. 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

    Time frame: From baseline to 6 months after baseline

  9. 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.

    Time frame: Baseline

  10. 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.

    Time frame: From baseline to 3 months after baseline

  11. 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.

    Time frame: From baseline to 6 months

  12. Persistence Outcomes at 3 Months

    Proportion of patients with ongoing Structum® prescription at 3 months

    Time frame: At 3 months after baseline

  13. Persistence Outcomes at 6 Months

    Proportion of patients with ongoing Structum® prescription at 6 months

    Time frame: At 6 months after baseline

  14. 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.

    Time frame: At 3 months after baseline

  15. 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.

    Time frame: At 6 months after baseline

Other outcomes

  1. 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

    Time frame: Baseline (inclusion)

  2. Spearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the SF-12 Questionnaire (Physical and Mental Components) at 3 Months

    Time frame: At 3 months after baseline

  3. 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

    Time frame: At 6 months after baseline

  4. 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

    Time frame: Baseline (inclusion)

  5. 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

    Time frame: At 3 months after baseline

  6. 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

    Time frame: At 6 months after baseline

  7. 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

    Time frame: Baseline (inclusion)

  8. 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

    Time frame: From baseline to 3 months after baseline

  9. 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

    Time frame: From baseline to 6 months after baseline

07

Results

Posted Sep 8, 2026
Limitations and caveats
One of the limitations was that this was an observational study. Another limitation was that there were few external comparators to interpret results, as few studies have been carried out on Structum® in the literature. In addition, while the BONe'S questionnaire has been published, it has not been validated in many other studies. Another potential source of bias was the fact that 15 BONe'S questionnaires were printed with a missing page mostly from one centre, resulting in several missing data.

Participant flow

Participant flow — Overall Study
MilestoneStructum® Arm
Started136
Completed124
Not completed12
Withdrew: Lost to follow-up4
Withdrew: Structum discontinuation6
Withdrew: Patient's decision2

Outcome measures

PrimaryOsteoarthritis (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.

Time frame:
At baseline (inclusion)
Reported as:
Mean · score on a scale
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
score on a scaleStructum® Arm
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 Baseline1158.2 ± 469.1
PrimaryCharlson 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.

Time frame:
At baseline (inclusion)
Reported as:
Mean · score on a scale
Charlson Comorbidity Index Score Measured at Baseline
score on a scaleStructum® Arm
Charlson Comorbidity Index Score Measured at Baseline2.6 ± 1.42
PrimaryTreatment 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

Time frame:
From 6 months before inclusion to inclusion (baseline)
Reported as:
Count of participants · Participants
Treatment History Received by the Patients in the Past 6 Months Before Inclusion
ParticipantsStructum® Arm
Previous treatment for knee osteoarthritis: yes36
Previous treatment for knee osteoarthritis: no100
SecondaryWestern 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.

Time frame:
From baseline (inclusion) to 3 months after baseline
Reported as:
Mean · score on a scale
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 3 Months
score on a scaleStructum® Arm
Total score at 3 months767.6 ± 506.0
Mean difference from baseline to 3 months-392.2 ± 455.5
SecondaryWestern 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.

Time frame:
From baseline to 6 months after baseline
Reported as:
Mean · score on a scale
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 6-months
score on a scaleStructum® Arm
Total score at 6 months541.6 ± 456.0
Mean difference in total score from baseline to 6 months-625.7 ± 482.1
SecondaryBONe'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.

Time frame:
At baseline (inclusion)
Reported as:
Mean · score on a scale
BONe's Questionnaire at Baseline
score on a scaleStructum® Arm
BONe's Questionnaire at Baseline35.6 ± 16.6
SecondaryBONe'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.

Time frame:
From baseline (inclusion) to 3 months after baseline
Reported as:
Mean · score on a scale
BONe's Outcome at 3 Months
score on a scaleStructum® Arm
Global score at 3 months26.6 ± 19.8
Mean difference in Global score from baseline to 3 months-10.0 ± 16.2
SecondaryBONe'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.

Time frame:
From baseline (inclusion) to 6 months after baseline
Reported as:
Mean · score on a scale
BONe's Outcome at 6 Months
score on a scaleStructum® Arm
Global score at 6 months20.2 ± 18.3
Mean difference in Global score from baseline to 6 months-15.9 ± 16.2
SecondaryShort 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.

Time frame:
At baseline (inclusion)
Reported as:
Mean · score on a scale
Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at Baseline
score on a scaleStructum® Arm
Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at Baseline36.1 ± 7.3
SecondaryShort 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.

Time frame:
From baseline to 3 months after baseline
Reported as:
Mean · score on a scale
Short Form Questionnaire With 12 Questions (SF-12) Outcome: Physical Score Component at 3 Months
score on a scaleStructum® Arm
Global score at 3 months41.1 ± 7.4
Mean difference in global score from baseline to 3 months5.0 ± 7.2
SecondaryShort 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

Time frame:
From baseline to 6 months after baseline
Reported as:
Mean · score on a scale
Short Form Questionnaire With 12 Questions (SF-12): Physical Score Component at 6 Months
score on a scaleStructum® Arm
Global score at 6 months43.5 ± 7.3
Mean difference in Global score from baseline to 6 months7.4 ± 7.5
SecondaryShort 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.

Time frame:
Baseline
Reported as:
Mean · score on a scale
Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at Baseline
score on a scaleStructum® Arm
Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at Baseline44.1 ± 9.7
SecondaryShort 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.

Time frame:
From baseline to 3 months after baseline
Reported as:
Mean · score on a scale
Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at 3 Months
score on a scaleStructum® Arm
Global score at 3 months47.7 ± 8.8
Mean difference in the Global score at 3 months11.9 ± 28.5
SecondaryShort 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.

Time frame:
From baseline to 6 months
Reported as:
Mean · score on a scale
Short Form Questionnaire With 12 Questions (SF-12): Mental Score Component at 6 Months
score on a scaleStructum® Arm
Global score at 6 months50.7 ± 8.7
Mean difference in Global score from baseline to 6 months7.4 ± 7.5
SecondaryPersistence Outcomes at 3 Months

Proportion of patients with ongoing Structum® prescription at 3 months

Time frame:
At 3 months after baseline
Reported as:
Count of participants · Participants
Persistence Outcomes at 3 Months
ParticipantsStructum® Arm
Persistence Outcomes at 3 Months128
SecondaryPersistence Outcomes at 6 Months

Proportion of patients with ongoing Structum® prescription at 6 months

Time frame:
At 6 months after baseline
Reported as:
Count of participants · Participants
Persistence Outcomes at 6 Months
ParticipantsStructum® Arm
Persistence Outcomes at 6 Months124
SecondaryGlobal 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.

Time frame:
At 3 months after baseline
Reported as:
Mean · score on a scale
Global Score of Patients Satisfaction, After First Dose of Structum®, at 3 Months
score on a scaleStructum® Arm
Global Score of Patients Satisfaction, After First Dose of Structum®, at 3 Months72.3 ± 20.1
SecondaryGlobal 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.

Time frame:
At 6 months after baseline
Reported as:
Mean · score on a scale
Global Score of Patient Satisfaction, After First Dose of Structum®, at 6 Months
score on a scaleStructum® Arm
Global Score of Patient Satisfaction, After First Dose of Structum®, at 6 Months75.0 ± 18.8
Other pre-specifiedSpearman 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

Time frame:
Baseline (inclusion)
Reported as:
Number · Spearman correlation coefficient r
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.
Spearman correlation coefficient rStructum® Arm
Physical component - Spearman correlation coefficient number-0.617
Mental component - Spearman correlation coefficient number-0.595
Statistical analysis
  • Structum® Arm · Spearman correlation · p = <0.0001 (The threshold for statistical significance is p = 0.05)
Other pre-specifiedSpearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the SF-12 Questionnaire (Physical and Mental Components) at 3 Months
Time frame:
At 3 months after baseline
Reported as:
Number · Spearman correlation coefficient r
Spearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the SF-12 Questionnaire (Physical and Mental Components) at 3 Months
Spearman correlation coefficient rStructum® Arm
Physical component Spearman correlation coefficient number-0.778
Mental component Spearman correlation coefficient number-0.708
Statistical analysis
  • Structum® Arm · Spearman correlation · p = <0.0001 (The threshold for statistical significance is p = 0.05)
Other pre-specifiedSpearman 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

Time frame:
At 6 months after baseline
Reported as:
Number · Spearman correlation coefficient r
Spearman Correlation Coefficient for the Correlation Between the BONe'S Questionnaire and the Short Form, SF-12 Questionnaire at 6 Months.
Spearman correlation coefficient rStructum® Arm
Physical component - Spearman correlation coefficient r-0.18
Mental component - Spearman correlation coefficient r-0.689
Statistical analysis
  • Structum® Arm · Spearman correlation · p = <0.0001 (The threshold for statistical significance is p = 0.05)
Other pre-specifiedSpearman 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

Time frame:
Baseline (inclusion)
Reported as:
Number · Spearman correlation coefficient r
Spearman Correlation Coefficient for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at Inclusion
Spearman correlation coefficient rStructum® Arm
Spearman Correlation Coefficient for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at Inclusion0.487
Statistical analysis
  • Structum® Arm · Spearman correlation · p = <0.0001 (The threshold for statistical significance is p = 0.05)
Other pre-specifiedSpearman 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

Time frame:
At 3 months after baseline
Reported as:
Number · Spearman correlation coefficient r
Spearman Correlation Coefficient and P Value for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at 3 Months
Spearman correlation coefficient rStructum® Arm
Spearman Correlation Coefficient and P Value for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at 3 Months0.735
Statistical analysis
  • Structum® Arm · Spearman correlation · p = <0.0001 (The threshold for statistical significance is p = 0.05)
Other pre-specifiedSpearman 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

Time frame:
At 6 months after baseline
Reported as:
Number · Spearman correlation coefficient r
Spearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at 6 Months.
Spearman correlation coefficient rStructum® Arm
Spearman Correlation Coefficient Value for the Correlation Between the BONe'S Questionnaire and the WOMAC Questionnaire at 6 Months.0.569
Statistical analysis
  • Structum® Arm · Spearman correlation · p = <0.0001 (The threshold for statistical significance is p = 0.05)
Other pre-specifiedChange 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

Time frame:
Baseline (inclusion)
Reported as:
Count of participants · Participants
Change in NSAIDs and Other Analgesics at Inclusion Compared to 6 Months Before Inclusion
ParticipantsStructum® Arm
No treatment in both periods compared1
Treatment stopped12
Reduced dosage4
Treatment stable14
Increased dosage2
New treatment18
Other pre-specifiedChanges 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

Time frame:
From baseline to 3 months after baseline
Reported as:
Count of participants · Participants
Changes in NSAIDs and Other Analgesics at 3 Months Compared to Inclusion
ParticipantsStructum® Arm
No treatment in both periods compared12
treatment stopped9
Reduced dosage1
Treatment stable27
Increased dosage0
New treatment1
Other pre-specifiedChange 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

Time frame:
From baseline to 6 months after baseline
Reported as:
Count of participants · Participants
Change in NSAIDs and Other Analgesics at 6 Months Compared to Inclusion
ParticipantsStructum® Arm
No treatment in both compared periods10
Treatment stopped17
Reduced dosage1
Treatment stable19
Increased dosage0
New treatment1

Adverse events

Collected over From inclusion to 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Structum® Arm0/136 (0%)0/136 (0%)9/136 (6.6%)
Most frequent other events
Most frequent other events
EventStructum® Arm
Drug ineffectiveGeneral disorders3/136
ArthralgiaMusculoskeletal and connective tissue disorders2/136
Spinal painMusculoskeletal and connective tissue disorders2/136
Abdominal pain upperGastrointestinal disorders1/136
MalaiseGeneral disorders1/136
DizzinessNervous system disorders1/136

Baseline characteristics

Age, Continuous
Age, Continuous(years)Structum® Arm
Mean65.3 ± 7.78
Sex: Female, Male
Sex: Female, Male(Participants)Structum® Arm
Female93
Male43
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Structum® Arm
Region of Enrollment
Region of Enrollment(participants)Structum® Arm
Poland136
Body Mass Index
Body Mass Index(KG/M²)Structum® Arm
Mean28.8 ± 4.2
08

Study locations

15 sites
  • Maciej Dołżyński
    Bialystok, 15-481, Poland
  • Piotr Ligocki
    Bydgoszcz, 85-091, Poland
  • Elżbieta Pietrus- Dunaszewska
    Katowice, 40-007, Poland
  • Bartlomiej Szpyra
    Krakow, 31-155, Poland
  • Alina Wołkowicz Mruk
    Krakow, 31-455, Poland
  • Andrzej Majer
    Kujakowice Gorn, 46-211, Poland
  • Agnieska WIAK
    Lubartów, 21-100, Poland
  • Wojciech Larczyński
    Nowy Dwór Gdański, 82-100, Poland
  • Sławomir Panek
    Olesno, 46-300, Poland
  • Marcin Milchert
    Szczecin, 71-497, Poland
  • Wojciech Roczniak
    Ustrzyki Dolne, Ustrzyki Dolne, Poland
  • Zdzisław Derleta
    Warsaw, 03-938, Poland
  • Michał Straburzyński
    Zielona Góra, 65-047, Poland
  • Mariusz Borowiecki
    Zielona Góra, 65-559, Poland
  • Viktor Kostiuk
    Żagań, 68-100, Poland
09

References and documents

Study documents

  • Study protocol · Dec 21, 2023
  • Statistical analysis plan · May 15, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06623773
Lead sponsor
Pierre Fabre Medicament
Responsible party
Sponsor
First posted
Oct 2, 2024
Start date
Jul 12, 2023
Primary completion
Oct 28, 2024
Completion
Oct 28, 2024
Results posted
Sep 8, 2026
Last update
Sep 8, 2026

Study contacts

PIOTR WILAND
principal investigator · Medical University of WROCLAW

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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