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NCT Number: NCT03911570

Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis

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.

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Key information

Conditions

Hand Osteoarthritis

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rheumatology Unit Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucosamine Sulfate

Drug

Therapy with the prescription formulation of crystalline glucosamine sulfate

Other names: acetaminophen, non steroidal anti-inflammatory drugs

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

    Time frame: Basal time; one month; three months; six months

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

Secondary outcomes

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

    Time frame: Basal time; one month; three months; six months

    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.

  2. Health Assessment Questionnaire (HAQ)

    Time frame: Basal time; one month; three months; six months

    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

  3. Medical Outcomes Study 36-Item Short Form (SF-36)

    Time frame: Basal time; one month; three months; six months

    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

  4. NSAIDs and/or acetaminophen consumption

    Time frame: Basal time; one month; three months; six months

    The acetaminophen and NSAIDs/COX-2 inhibitors consumption was calculated asking the patients at each visit the number of tablets taken weekly.

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2019
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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