Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-07

Study Completion Date

2021-12-01

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.

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Detailed Description

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Conditions

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Erosive Osteoarthritis of the Hand

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Prescription-grade Crystalline Glucosamine Sulfate Group (pCGS Group)

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.

Glucosamine Sulfate

Intervention Type DRUG

Treatment for at least 6 months with prescription-grade crystalline Glucosamine Sulfate in addition to conventional treatment

Control Group

Control Group includes patients treated with conventional therapy alone for at least 6 consecutive months.

No interventions assigned to this group

Interventions

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Glucosamine Sulfate

Treatment for at least 6 months with prescription-grade crystalline Glucosamine Sulfate in addition to conventional treatment

Intervention Type DRUG

Other Intervention Names

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Acetaminophen Non-steroidal anti-inflammatory drugs

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.

Minimum Eligible Age

48 Years

Maximum Eligible Age

87 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No