Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis

Erosive Osteoarthritis of the Hand Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05237596
• Other study ID #: pCGS_EHOA
• Status: Completed
• Start date: January 7, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2022
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Years to 87 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erosive Osteoarthritis of the Hand
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Italy	Rheumatology Unit Azienda Ospedaliera Universitaria Senese	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0-100 mm scale with 0 representing the absence of pain	Basal time; three months; six months
Primary	Difference between the two groups in the change of the Functional Index for Hand Osteoarthritis (FIHOA) score	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	Basal time; three months; six months
Secondary	Difference between the two groups in the change in the duration of morning stiffness	VAS stiffness is measured in minutes and based on the self-report of patients	Basal time; three months; six months
Secondary	Difference between the two groups in the change of HAQ	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	Basal time; three months; six months
Secondary	Difference between the two groups in the change of SF-36	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	Basal time; three months; six months
Secondary	NSAIDs and/or acetaminophen consumption	The acetaminophen and NSAIDs/COX-2 inhibitors consumption was calculated asking the patients at each visit the number of tablets taken weekly.	Basal time; three months; six months
Secondary	OMERACT/OARSI criteria responders	percentage of treatment responders at 3 and 6 months, according to the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) criteria	Basal time; three months; six months