Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis (NCT05237596) | Clinical Trial Compass
CompletedNot Applicable
Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis
Italy123 participantsStarted 2021-01-07
Plain-language summary
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.
Who can participate
Age range
48 Years – 87 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Basal time; three months; six months
2
Difference between the two groups in the change of the Functional Index for Hand Osteoarthritis (FIHOA) score