NCT03911570

Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: University of Siena · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Glucosamine Sulfate	Therapy with the prescription formulation of crystalline glucosamine sulfate

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-01-01
• Completion: 2019-02-01
• First posted: 2019-04-11
• Last updated: 2019-04-12

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study