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Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03911570
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
fioravanti antonella, University of Siena

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.

Condition or disease Intervention/treatment
Hand Osteoarthritis Drug: Glucosamine Sulfate

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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Symptomatic Effects of Long-term Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis: a Comparative Retrospective Study
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911570


Locations
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Italy
Rheumatology Unit Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100
Sponsors and Collaborators
University of Siena

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: fioravanti antonella, Symptomatic Effects of Long-term Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis: a Comparative Retrospective Study, University of Siena
ClinicalTrials.gov Identifier: NCT03911570    
Other Study ID Numbers: GS-HOA
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics