Status:
COMPLETED
Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis
Lead Sponsor:
University of Siena
Conditions:
Erosive Osteoarthritis of the Hand
Eligibility:
All Genders
48-87 years
Brief 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, i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT05237596
Start Date
January 7 2021
End Date
December 1 2021
Last Update
March 4 2022
Active Locations (1)
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1
Rheumatology Unit Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100