Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis

NCT03911570 | Completed FDA Drug

• 1 other identifier: GS-HOA
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand Osteoarthritis

Outcome Measures

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

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

  Basal time; one month; three months; six months

Secondary Outcomes (4)

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

  Basal time; one month; three months; six months

• Health Assessment Questionnaire (HAQ)

  Basal time; one month; three months; six months

• Medical Outcomes Study 36-Item Short Form (SF-36)

  Basal time; one month; three months; six months

• NSAIDs and/or acetaminophen consumption

  Basal time; one month; three months; six months

Study Arms (2)

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

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

Interventions

Glucosamine Sulfate DRUG

Therapy with the prescription formulation of crystalline glucosamine sulfate

Also known as: acetaminophen, non steroidal anti-inflammatory drugs

Control Group; Glucosamine Sulfate Group (GS Group)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

Rheumatology Unit Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Related Publications (1)

• 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.

  PMID: 31429006 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: Symptomatic Effects of Long-term Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis: a Comparative Retrospective Study

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: September 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)