Hand OsteoarthritisNCT03911570
Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis
An observational study of Hand Osteoarthritis, run by University of Siena at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Glucosamine Sulfate
- Type of treatment
- Pill or oral medicine
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2018to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Rheumatology Unit Azienda Ospedaliera Universitaria Senese
Siena, 53100
About this study
Official title: 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.
- Conditions
- Hand Osteoarthritis
- Being tested
- Glucosamine Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosamine SulfateDrug
Also called acetaminophen, non steroidal anti-inflammatory drugs
Therapy with the prescription formulation of crystalline glucosamine sulfate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Glucosamine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Basal time; one month; three months; six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Sep 2018
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fioravanti antonella, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911570
- Sponsor's protocol ID
- GS-HOA
- Status last verified
- Apr 2019
- First submitted
- 9 Apr 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31429006
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Effects of Long-term Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis: a Comparative Retrospective Study
- ClinicalTrials.gov ID
- NCT03911570
- Acronym / sponsor ID
- GS-HOA
- Conditions
- Hand Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucosamine Sulfate Group (GS Group) | – | Drug: Glucosamine SulfateGS 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. |
| Control Group | – | Drug: Glucosamine SulfateControl 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). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucosamine SulfateAlso: acetaminophen, non steroidal anti-inflammatory drugsTherapy with the prescription formulation of crystalline glucosamine sulfate | Drug | Control Group, Glucosamine Sulfate Group (GS Group) |
Primary outcome
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
4 secondary outcomes
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
Health Assessment Questionnaire (HAQ)
Time frame: Basal time; one month; three months; six months
Medical Outcomes Study 36-Item Short Form (SF-36)
Time frame: Basal time; one month; three months; six months
NSAIDs and/or acetaminophen consumption
Time frame: Basal time; one month; three months; six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Derived from this study: PubMed 31429006Tenti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Osteoarthritis, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.