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The objective of this study is to evaluate the efficacy of prescription-grade Crystalline Glucosamine Sulfate (pCGS), as an add-on treatment to conventional therapy, compared to usual therapy alone, in patients with erosive osteoarthritis of the hand (EHOA).
This is a 6-months retrospective study including patients with concomitant gonarthrosis and EHOA, defined as the presence of central erosion in at least two interphalangeal joints. Eligibility criteria are symptoms duration for at least 3 months, with a global hand pain score ≥40 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score ≥6. The participants are stratified into two groups based on whether or not pCGS, at the daily dose of 1500 mg, was added to the conventional therapy for hand osteoarthritis (HOA). The latter consists of education and training in ergonomic principles, exercise and the use on-demand of acetaminophen or oral non-steroidal anti-inflammatory drugs. Patients are evaluated at baseline, after 3 and 6 months. Primary outcome measures are the change from baseline to month 6 in VAS and in FIHOA score. Secondary outcomes are duration of morning stiffness, health assessment questionnaire (HAQ), medical outcomes study 36-item short form (SF-36), symptomatic drugs consumption and percentage of treatment responders, according to the OMERACT/OARSI criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prescription-grade Crystalline Glucosamine Sulfate Group (pCGS Group) | pCGS Group includes patients treated with pCGS (Dona®, VIATRIS), in sachets of powder for oral solution, at the dose of 1500 mg glucosamine sulfate once daily, for a total period of 6 consecutive months according to the approved indication for knee OA, in addition to conventional therapy for HOA. |
| |
| Control Group | Control Group includes patients treated with conventional therapy alone for at least 6 consecutive months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucosamine Sulfate | Drug | Treatment for at least 6 months with prescription-grade crystalline Glucosamine Sulfate in addition to conventional treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the two groups in the change of the patient's assessment of global hand pain on a 0- 100 mm Visual Analogue Scale | 0-100 mm scale with 0 representing the absence of pain | Basal time; three months; six months |
| Difference between the two groups in the change of the Functional Index for Hand Osteoarthritis (FIHOA) score | The FIHOA score represents a quantitative measure of functional disability of the hands; it contains 10 items and is an investigator-administered questionnaire. Patients are asked to answer each item using a four-point Likert scale: 0 = possible without difficulty, 1 = possible with slight difficulty, 2 = possible with considerable difficulty, 3 = impossible; the range of scores is 0-30 and the highest values indicate the worst functionality. The validate Italian version of FIHOA is used for the present study | Basal time; three months; six months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the two groups in the change in the duration of morning stiffness | VAS stiffness is measured in minutes and based on the self-report of patients | Basal time; three months; six months |
| Difference between the two groups in the change of HAQ |
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Inclusion Criteria:
Exclusion Criteria:
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The participants are stratified into two groups (pCGS Group and Control Group) based on whether or not prescription-grade crystalline GS treatment, prescribed for the actually approved indication of knee OA, was added to the conventional therapy. This stratification is based on regrouping patients with similar clinical characteristics at baseline.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Unit Azienda Ospedaliera Universitaria Senese | Siena | 53100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35637324 | Derived | Tenti S, Veronese N, Cheleschi S, Seccafico I, Bruyere O, Reginster JY, Fioravanti A. Prescription-grade crystalline glucosamine sulfate as an add-on therapy to conventional treatments in erosive osteoarthritis of the hand: results from a 6-month observational retrospective study. Aging Clin Exp Res. 2022 Jul;34(7):1613-1625. doi: 10.1007/s40520-022-02151-7. Epub 2022 May 30. |
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| ID | Term |
|---|---|
| D005944 | Glucosamine |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
| D000083 | Acetanilides |
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|
HAQ is a self administered questionnaire developed to measure disability consisting of 8 sections: dressing arising, eating, walking, hygiene, reach, grip, and activities and ranging from 0 to 3 with a higher score corresponding to worse disability |
| Basal time; three months; six months |
| Difference between the two groups in the change of SF-36 | SF-36 is a widely used measure of health and wellbeing, including two main domains, mental and physical component summary (MCS and PCS respectively), that investigates 8 different areas of perceived health, such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health. Scores range from "0 to 100" where "0" indicates the worst condition and "100" indicates the best possible condition | Basal time; three months; six months |
| NSAIDs and/or acetaminophen consumption | The acetaminophen and NSAIDs/COX-2 inhibitors consumption was calculated asking the patients at each visit the number of tablets taken weekly. | Basal time; three months; six months |
| OMERACT/OARSI criteria responders | percentage of treatment responders at 3 and 6 months, according to the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) criteria | Basal time; three months; six months |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |