Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis

NCT05237596 | Completed FDA Drug

• 1 other identifier: pCGS_EHOA
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Erosive Osteoarthritis of the Hand

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Difference between the two groups in the change in the duration of morning stiffness

  Basal time; three months; six months

• Difference between the two groups in the change of HAQ

  Basal time; three months; six months

• Difference between the two groups in the change of SF-36

  Basal time; three months; six months

• NSAIDs and/or acetaminophen consumption

  Basal time; three months; six months

• OMERACT/OARSI criteria responders

  Basal time; three months; six months

Study Arms (2)

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.

Drug: Glucosamine Sulfate

Control Group

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

Interventions

Glucosamine Sulfate DRUG

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

Also known as: Acetaminophen, Non-steroidal anti-inflammatory drugs

Prescription-grade Crystalline Glucosamine Sulfate Group (pCGS Group)

Eligibility Criteria

• Age: 48 Years - 87 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

Rheumatology Unit Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Related Publications (1)

• 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.

  PMID: 35637324 DERIVED

MeSH Terms

Interventions

Glucosamine; Acetaminophen

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 14, 2022
• Study Start: January 7, 2021
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)