Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Erosive Osteoarthritis of the Hand: Efficacy of Prescription-grade Crystalline Glucosamine Sulfate as an add-on Therapy to Conventional Treatments

Conditions
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Erosive Osteoarthritis of the Hand

Intervention / Treatment
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* Drug: Glucosamine Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Erosive Hand Osteoarthritis, defined as the presence of the classical central erosion in at least two interphalangeal joints Treatment for at least 6 consecutive months with prescription-grade crystalline GS at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone. Symptoms duration for at least 3 months defined as global hand pain score superior to 40 mm on a 0-100 VAS and a FIHOA score of at least 6. Exclusion Criteria: Medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, or the presence of any other rheumatic diseases that could cause secondary OA, such as hemochromatosis Concomitant therapy with SYSADOAs, other than pCGS, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months Concomitant treatment with intra-muscular or intra-venous bisphosphonates in the previous 6 months Contraindications or special warnings for pCGS presented in the data sheet.

Ages Eligible for Study
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Minimum Age: 48 Years
Maximum Age: 87 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prescription-grade Crystalline Glucosamine Sulfate Group (pCGS Group)<br>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. | Drug: Glucosamine Sulfate<br>* Treatment for at least 6 months with prescription-grade crystalline Glucosamine Sulfate in addition to conventional treatment<br>* Other names: Non-steroidal anti-inflammatory drugs;|
| Control Group<br>Control Group includes patients treated with conventional therapy alone for at least 6 consecutive months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |