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NCT05237596
Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis
trial testing Glucosamine Sulfate in Erosive Osteoarthritis of the Hand in 123 participants. Completed in 1 December 2021.
1 June 2021
Quick facts
| Lead sponsor | University of Siena |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 123 |
| Start date | 7 January 2021 |
| Primary completion | 1 June 2021 |
| Estimated completion | 1 December 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Glucosamine Sulfate — full drug profile →
Conditions studied
- Erosive Osteoarthritis of the Hand — all drugs for Erosive Osteoarthritis of the Hand →
Sponsor
University of Siena
Who can join
Adults 48 to 87, any sex, with Erosive Osteoarthritis of the Hand. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05237596
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Related trials
Other trials of Glucosamine Sulfate
Trials testing the same drug.
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- NCT03911570 — Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis · completed
- NCT03201276 — Individual Differences in Glucosamine Sulfate Exposure Levels · unknown
Other University of Siena trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05237596 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Siena
- Last refreshed: 4 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05237596.
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