Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis

Symptomatic Effects of Long-term Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis: a Comparative Retrospective Study

The objective of this study is to retrospectively evaluate the symptomatic effects of crystalline glucosamine sulfate (GS), prescribed for the actually approved indication of knee OA, in addition to conventional therapy, in comparison to the conventional therapy alone in patients with primary hand osteoarthritis (HOA).This is a 6-months retrospective comparative study including patients with concomitant knee and primary HOA, according to the ACR criteria. To be eligible the patients had to present clinical symptoms of hand OA for at least 3 months, defined as global hand pain score superior to 40 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score of at least 6. Furthermore, the patients have had a radiographic evidence of HOA within the previous 6 months with a Kellgren-Lawrence score of II-III. The participants are stratified into two groups based on whether or not crystalline GS at the daily dose of 1500 mg was added to the conventional therapy for HOA, including exercise, acetaminophen and non steroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase (COX)-2 inhibitors. Primary outcome measures are the difference between the two groups in the change of VAS pain and in the FIHOA, from baseline after 6 months. Secondary outcomes were health assessment questionnaire (HAQ), medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption.

Study Overview

• Status: Completed
• Conditions: Hand Osteoarthritis
• Intervention / Treatment: Drug: Glucosamine Sulfate

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• Italy
  • Siena, Italy, 53100
    • Rheumatology Unit Azienda Ospedaliera Universitaria Senese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The participants were stratified into two groups based on whether or not (GS Group and Control Group) crystalline GS treatment, prescribed for the actually approved indication of knee OA, was added to the conventional therapy. This stratification was based on regrouping patients with similar clinical characteristics at baseline.

Description

Inclusion Criteria:

• Mono or bilateral primary HOA and concomitant knee OA, according to the American College of Rheumatology (ACR) criteria
• Treatment for at least 6 consecutive months with crystalline GS at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone.
• HOA 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.
• Radiographic evidence of HOA within the previous 6 months with a radiological score of II-III (using the Kellgren method).

Exclusion Criteria:

• Erosive Osteoarthritis of the hand
• Medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, monarticular post-traumatic OA of the finger, a history or the presence of any other rheumatic diseases that could cause secondary OA, such as hemochromatosis.
• Ongoing therapy with opioid analgesics and any kind of topical treatment
• Therapy with SYSADOAs other than GS, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months.
• Contraindications or special warnings for GS presented in the data sheet.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Glucosamine Sulfate Group (GS Group); GS Group is treated for at least 6 consecutive months with a single daily dose of 1500 mg of crystalline GS (powder sachets), in addition to conventional therapy.	Drug: Glucosamine Sulfate; Therapy with the prescription formulation of crystalline glucosamine sulfate; Other Names: acetaminophen; non steroidal anti-inflammatory drugs
Control Group; Control Group receive only usual care therapy. The conventional therapy includes exercise for HOA and treatment with acetaminophen or oral NSAIDs or COX-2 inhibitors (150 mg Diclofenac tablets, 20 mg Piroxicam tablets, 550 mg Naproxen tablets, 200 mg Aceclofenac, 600 mg Ibuprofen tablets, 200 mg Celecoxib tablets, 60 mg Etoricoxib tablets).	Drug: Glucosamine Sulfate; Therapy with the prescription formulation of crystalline glucosamine sulfate; Other Names: acetaminophen; non steroidal anti-inflammatory drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; one month; three months; six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; one month; three months; six months
Health Assessment Questionnaire (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; one month; three months; six months
Medical Outcomes Study 36-Item Short Form (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; one month; three months; six months
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; one month; three months; six months

Collaborators and Investigators

• Sponsor: University of Siena

Publications and helpful links

General Publications

• Tenti S, Giordano N, Mondanelli N, Giannotti S, Maheu E, Fioravanti A. A retrospective observational study of glucosamine sulfate in addition to conventional therapy in hand osteoarthritis patients compared to conventional treatment alone. Aging Clin Exp Res. 2020 Jun;32(6):1161-1172. doi: 10.1007/s40520-019-01305-4. Epub 2019 Aug 19.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (ACTUAL): April 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Antipyretics; Anti-Inflammatory Agents; Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: GS-HOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No