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NCT Number: NCT05237596

Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis

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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Key information

Conditions

Erosive Osteoarthritis of the Hand

Age range

48 year–87 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rheumatology Unit Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucosamine Sulfate

Drug

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

Other names: Acetaminophen, Non-steroidal anti-inflammatory drugs

Primary outcomes

  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

    Time frame: Basal time; three months; six months

    0-100 mm scale with 0 representing the absence of pain

  2. Difference between the two groups in the change of the Functional Index for Hand Osteoarthritis (FIHOA) score

    Time frame: Basal time; three months; six months

    The FIHOA score represents a quantitative measure of functional disability of the hands; it contains 10 items and is an investigator-administered questionnaire. Patients are asked to answer each item using a four-point Likert scale: 0 = possible without difficulty, 1 = possible with slight difficulty, 2 = possible with considerable difficulty, 3 = impossible; the range of scores is 0-30 and the highest values indicate the worst functionality. The validate Italian version of FIHOA is used for the present study

Secondary outcomes

  1. Difference between the two groups in the change in the duration of morning stiffness

    Time frame: Basal time; three months; six months

    VAS stiffness is measured in minutes and based on the self-report of patients

  2. Difference between the two groups in the change of HAQ

    Time frame: Basal time; three months; six months

    HAQ is a self administered questionnaire developed to measure disability consisting of 8 sections: dressing arising, eating, walking, hygiene, reach, grip, and activities and ranging from 0 to 3 with a higher score corresponding to worse disability

  3. Difference between the two groups in the change of SF-36

    Time frame: Basal time; three months; six months

    SF-36 is a widely used measure of health and wellbeing, including two main domains, mental and physical component summary (MCS and PCS respectively), that investigates 8 different areas of perceived health, such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health. Scores range from "0 to 100" where "0" indicates the worst condition and "100" indicates the best possible condition

  4. NSAIDs and/or acetaminophen consumption

    Time frame: Basal time; three months; six months

    The acetaminophen and NSAIDs/COX-2 inhibitors consumption was calculated asking the patients at each visit the number of tablets taken weekly.

  5. OMERACT/OARSI criteria responders

    Time frame: Basal time; three months; six months

    percentage of treatment responders at 3 and 6 months, according to the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) criteria

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study title

Erosive Osteoarthritis of the Hand: Efficacy of Prescription-grade Crystalline Glucosamine Sulfate as an add-on Therapy to Conventional Treatments

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 14, 2022
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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