Knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Sponsors
Bio Minerals NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Males and females between the ages of 18 and 75 years old 3. Females must use an approved form of birth control or be postmenopausal or be surgically sterile 4. OA of the knee as confirmed by radiography (weight-bearing, anteroposterior radiograph of the target knee: Kellgren and Lawrence grade II and III) during the screening visit or by a recent radiograph (50 years 5.4. Crepitus on active joint motion 5.5. Morning stiffness lasting 0 9. Physically active: Steinbrocker Class I - III
Exclusion criteria
Exclusion criteria: 1. Participant unable to understand the study procedures and/or not having given written informed consent and/or not wishing to participate in one of the subsequent therapeutic intervention protocols 2. Poor general health interfering with compliance or assessment 3. Unlikely to co-operate fully in the study 4. Participating in another clinical trial in the last 90 days 5. Pregnancy or breastfeeding 6. Morning stiffness >30 minutes in duration 7. Subjects with a swollen or warm joint thought to be secondary to gout, pseudogout or sepsis 8. Active rheumatoid arthritis 9. Paget’s disease of bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemachromatosis, Wilson’s disease and primary osteochondromatosis 10. Significant injury to the target joint within 6 months of trial start 11. Disease of the spine or lower extremity joints of sufficient degree to affect the assessment of the target joint 12. New physical activity i.e. physical activity which was not present prior to the screening visit 13. Recent or current alcohol abuse (consumption levels of more than 28 units 25per week) and drug abuse 14. Arthroplasty in the target knee and joint surgery of the target knee within 2 years prior to the start of the study 15. Participants who have received chondrocyte transplants in any lower extremity joint 16. Participants who belong in a high-risk group for HIV 17. Clinically significant medical abnormalities which would make the subject unsuitable for the study as judged by the investigator 18. Participant has renal failure, documented history of stroke, myocardial infarct or cancer 19. Concomitant and previous medication: 19.1. Less than 28 days between the topical or systemic treatment with hyaluronic acid, glucosamine sulphate, glucosamine HCl, n-acetyl glucosamine and derivatives thereof such as chondroitin sulphate, glycosaminoglycans and the start of the study 19.2. Less than 3 months between the treatment with a slow-acting drug for symptom relief and the start of the study 19.3. Participants who have used previous topical and/or systemic treatment with NSAIDs or analgesics, different from paracetamol, such asibuprofen, diclofenac, acetyl salicylic acid, piroxicam and indomethacin in a 14 days period prior to the start of the study 19.4. Participants who have used medications with MMP-inhibitory properties (e.g. tetracyclines or structurally related compounds), or took oral (systemic, > 10 days duration) glucocorticoids in a 28 days period prior to start of the study 19.5. Participants who have used compounds containing agents claiming to possess disease/structure modifying properties (e.g. diacerhein) in a 28 days period prior to the start of the study 19.6. Participants who received intra-articular injections in the target knee of glucocorticoids within 3 months of the start of the study or any other injection (e.g. hyaluronic acid) within 6 months prior to the start of the study 19.7. Concomitant and previous supplementation with food supplements containing horsetail extract, bamboo e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sum of physical function, stiffness and pain scores measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total index at baseline and 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The sum of functional, stiffness and pain scores measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total index at baseline, 2, 6, 12, 18, 24 and 36 weeks 2. Pain scores measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale at baseline, 2, 6, 12, 18, 24 and 36 weeks 3. Physical function scores measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscale at baseline, 2, 6, 12, 18, 24 and 36 weeks 4. Stiffness scores measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale at baseline, 2, 6, 12, 18, 24 and 36 weeks 5. The subject's global assessment of response to treatment measured using a visual analogue scale 100 mm at baseline, 2, 6, 12, 18, 24 and 36 weeks 6. Paracetamol intake measured using a diary and counting the remaining medication at 2, 6, 12, 18, 24 and 36 weeks 7. Biomarkers of collagen type II degradation and cartilage oligomeric matrix measured in serum and urine samples taken at baseline, 2, 6, 12, 18, 24 and 36 weeks 8. Response to treatment, defined by the OsteoArthritis Research Society International (OARSI) and Outcome Measures in Rheumatology Group (OMERACT) committees as at least 50% (or absolute score of 20) improvement in pain scores or improvement in at least two of the three following: at least 20% (or absolute score of 10) improvement in pain scores, at least 20% (or absolute score of 10) improvement in physical function scores, at least 20% (or absolute score of 10) improvement in subjects global assessment. The pain and physical function score scores are measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function subscores. The subject's global assessment is measured using a 1 | — |
Countries
Belgium, Czech Republic
Contacts
Public ContactIne De Cock
Outcome results
None listed