Clinical trial NCT05237596: Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis
Official title: Erosive Osteoarthritis of the Hand: Efficacy of Prescription-grade Crystalline Glucosamine Sulfate as an add-on Therapy to Conventional Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erosive Osteoarthritis of the Hand
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 123
Sex: ALL
Minimum age (years): 48
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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, 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: Difference between the two groups in the change of the Functional Index for Hand Osteoarthritis (FIHOA) score
timeFrame: Basal time; three months; six months
Secondary outcomes:
measure: Difference between the two groups in the change in the duration of morning stiffness
timeFrame: Basal time; three months; six months
measure: Difference between the two groups in the change of HAQ
timeFrame: Basal time; three months; six months
measure: Difference between the two groups in the change of SF-36
timeFrame: Basal time; three months; six months
measure: NSAIDs and/or acetaminophen consumption
timeFrame: Basal time; three months; six months
measure: OMERACT/OARSI criteria responders
timeFrame: Basal time; three months; six months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Rheumatology Unit Azienda Ospedaliera Universitaria Senese
Study officials:
References:
citation: 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.