Erosive Osteoarthritis of the HandNCT05237596
Prescription-grade Crystalline Glucosamine Sulfate Therapy in Erosive Hand Osteoarthritis
An observational study of Erosive Osteoarthritis of the Hand, run by University of Siena at 1 site in Italy.
Trial summary
The objective of this study is to evaluate the efficacy of prescription-grade Crystalline Glucosamine Sulfate (pCGS), as an add-on treatment to conventional therapy, compared to usual therapy alone, in patients with erosive osteoarthritis of the hand (EHOA). Read more about this study
- Who is it for?
- Ages 48 to 87 years
- Conditions the study is for
- Erosive Osteoarthritis of the Hand
- What is being tested?
- Glucosamine Sulfate
- Type of treatment
- Pill or oral medicine
- How many people
- 123 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2021to 1 Dec 2021
- 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 48 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants are stratified into two groups (pCGS Group and Control Group) based on whether or not prescription-grade crystalline GS treatment, prescribed for the actually approved indication of knee OA, was added to the conventional therapy. This stratification is based on regrouping patients with similar clinical characteristics at baseline.
Who may be able to join
- Erosive Hand Osteoarthritis, defined as the presence of the classical central erosion in at least two interphalangeal joints
- Treatment for at least 6 consecutive months with prescription-grade crystalline GS at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone.
- 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.
Who cannot join
- Medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, or the presence of any other rheumatic diseases that could cause secondary OA, such as hemochromatosis
- Concomitant therapy with SYSADOAs, other than pCGS, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months
- Concomitant treatment with intra-muscular or intra-venous bisphosphonates in the previous 6 months
- Contraindications or special warnings for pCGS 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: Erosive Osteoarthritis of the Hand: Efficacy of Prescription-grade Crystalline Glucosamine Sulfate as an add-on Therapy to Conventional Treatments
The objective of this study is to evaluate the efficacy of prescription-grade Crystalline Glucosamine Sulfate (pCGS), as an add-on treatment to conventional therapy, compared to usual therapy alone, in patients with erosive osteoarthritis of the hand (EHOA).
This is a 6-months retrospective study including patients with concomitant gonarthrosis and EHOA, defined as the presence of central erosion in at least two interphalangeal joints. Eligibility criteria are symptoms duration for at least 3 months, with a global hand pain score ≥40 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score ≥6. The participants are stratified into two groups based on whether or not pCGS, at the daily dose of 1500 mg, was added to the conventional therapy for hand osteoarthritis (HOA). The latter consists of education and training in ergonomic principles, exercise and the use on-demand of acetaminophen or oral non-steroidal anti-inflammatory drugs. Patients are evaluated at baseline, after 3 and 6 months. Primary outcome measures are the change from baseline to month 6 in VAS and in FIHOA score. Secondary outcomes are duration of morning stiffness, health assessment questionnaire (HAQ), medical outcomes study 36-item short form (SF-36), symptomatic drugs consumption and percentage of treatment responders, according to the OMERACT/OARSI criteria.
- Conditions
- Erosive Osteoarthritis of the Hand
- 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
Treatment for at least 6 months with prescription-grade crystalline Glucosamine Sulfate in addition to conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Prescription-grade Crystalline Glucosamine Sulfate Group (pCGS Group) | pCGS Group includes patients treated with pCGS (Dona®, VIATRIS), in sachets of powder for oral solution, at the dose of 1500 mg glucosamine sulfate once daily, for a total period of 6 consecutive months according to the approved indication for knee OA, in addition to conventional therapy for HOA. Receives: Drug: Glucosamine Sulfate | |
| Control Group | Control Group includes patients treated with conventional therapy alone for at least 6 consecutive months. |
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; three months; six months
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; three months; six months
Secondary outcomes (5)
Difference between the two groups in the change in the duration of morning stiffness
VAS stiffness is measured in minutes and based on the self-report of patients
Measured: Basal time; three months; six months
Difference between the two groups in the change of 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; three months; six months
Difference between the two groups in the change of 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; 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; three months; six months
OMERACT/OARSI criteria responders
percentage of treatment responders at 3 and 6 months, according to the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) criteria
Measured: Basal time; 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 posted14 Feb 2022
- Study start7 Jan 2021
- Primary completion1 Jun 2021
- Study completion1 Dec 2021
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 Erosive Osteoarthritis of the HandStudies 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
- 123 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
- NCT05237596
- Sponsor's protocol ID
- pCGS_EHOA
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tenti S, Veronese N, Cheleschi S, Seccafico I, Bruyere O, Reginster JY, Fioravanti A. Prescription-grade crystalline glucosamine sulfate as an add-on therapy to conventional treatments in erosive osteoarthritis of the hand: results from a 6-month observational retrospective study. Aging Clin Exp Res. 2022 Jul;34(7):1613-1625. doi: 10.1007/s40520-022-02151-7. Epub 2022 May 30.
PubMed 35637324
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erosive Osteoarthritis of the Hand: Efficacy of Prescription-grade Crystalline Glucosamine Sulfate as an add-on Therapy to Conventional Treatments
- ClinicalTrials.gov ID
- NCT05237596
- Acronym / sponsor ID
- pCGS_EHOA
- Conditions
- Erosive Osteoarthritis of the Hand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 14 Feb 2022 (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 evaluate the efficacy of prescription-grade Crystalline Glucosamine Sulfate (pCGS), as an add-on treatment to conventional therapy, compared to usual therapy alone, in patients with erosive osteoarthritis of the hand (EHOA).
This is a 6-months retrospective study including patients with concomitant gonarthrosis and EHOA, defined as the presence of central erosion in at least two interphalangeal joints. Eligibility criteria are symptoms duration for at least 3 months, with a global hand pain score ≥40 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score ≥6. The participants are stratified into two groups based on whether or not pCGS, at the daily dose of 1500 mg, was added to the conventional therapy for hand osteoarthritis (HOA). The latter consists of education and training in ergonomic principles, exercise and the use on-demand of acetaminophen or oral non-steroidal anti-inflammatory drugs. Patients are evaluated at baseline, after 3 and 6 months. Primary outcome measures are the change from baseline to month 6 in VAS and in FIHOA score. Secondary outcomes are duration of morning stiffness, health assessment questionnaire (HAQ), medical outcomes study 36-item short form (SF-36), symptomatic drugs consumption and percentage of treatment responders, according to the OMERACT/OARSI criteria.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescription-grade Crystalline Glucosamine Sulfate Group (pCGS Group) | – | Drug: Glucosamine SulfatepCGS Group includes patients treated with pCGS (Dona®, VIATRIS), in sachets of powder for oral solution, at the dose of 1500 mg glucosamine sulfate once daily, for a total period of 6 consecutive months according to the approved indication for knee OA, in addition to conventional therapy for HOA. |
| Control Group | – | –Control Group includes patients treated with conventional therapy alone for at least 6 consecutive months. |
Who may qualify
- Ages
- 48 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants are stratified into two groups (pCGS Group and Control Group) based on whether or not prescription-grade crystalline GS treatment, prescribed for the actually approved indication of knee OA, was added to the conventional therapy. This stratification is based on regrouping patients with similar clinical characteristics at baseline.
Key inclusion criteria (3 listed)
- Erosive Hand Osteoarthritis, defined as the presence of the classical central erosion in at least two interphalangeal joints
- Treatment for at least 6 consecutive months with prescription-grade crystalline GS at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone.
- 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.
Key exclusion criteria (4 listed)
- Medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, or the presence of any other rheumatic diseases that could cause secondary OA, such as hemochromatosis
- Concomitant therapy with SYSADOAs, other than pCGS, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months
- Concomitant treatment with intra-muscular or intra-venous bisphosphonates in the previous 6 months
- Contraindications or special warnings for pCGS 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 drugsTreatment for at least 6 months with prescription-grade crystalline Glucosamine Sulfate in addition to conventional treatment | Drug | Prescription-grade Crystalline Glucosamine Sulfate Group (pCGS 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; three months; six months
0-100 mm scale with 0 representing the absence of pain
Difference between the two groups in the change of the Functional Index for Hand Osteoarthritis (FIHOA) score
Time frame: Basal time; 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
5 secondary outcomes
Difference between the two groups in the change in the duration of morning stiffness
Time frame: Basal time; three months; six months
Difference between the two groups in the change of HAQ
Time frame: Basal time; three months; six months
Difference between the two groups in the change of SF-36
Time frame: Basal time; three months; six months
NSAIDs and/or acetaminophen consumption
Time frame: Basal time; three months; six months
OMERACT/OARSI criteria responders
Time frame: Basal time; 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 4 Mar 2022.
- Derived from this study: PubMed 35637324Tenti S, Veronese N, Cheleschi S, Seccafico I, Bruyere O, Reginster JY, Fioravanti A. Prescription-grade crystalline glucosamine sulfate as an add-on therapy to conventional treatments in erosive osteoarthritis of the hand: results from a 6-month observational retrospective study. Aging Clin Exp Res. 2022 Jul;34(7):1613-1625. doi: 10.1007/s40520-022-02151-7. Epub 2022 May 30.
- 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 Erosive Osteoarthritis of the Hand, 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 3 inclusion and 4 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 4 Mar 2022. 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; three months; six months). The study lists 2 primary outcomes in all. 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 NCT05237596, 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 4 Mar 2022.