Multiple SclerosisNCT05811689
Trabecular Bone Score in Multiple Sclerosis
An observational study of Multiple Sclerosis and Endocrine System Diseases, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
Assess bone quality in MS patients through TBS and evaluate the potential effects exerted by different drugs used in MS treatment, which may affect BMD and TBS in MS patients Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Endocrine System Diseases, Neurologic Disorder
- What is being tested?
- sm tbs group
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2021to 15 Feb 2023
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 subjects aged between 20 and 65, belonging to the MS Outpatient Clinic of the IRCCS Centro Neurolesi Bonino Pulejo will be recruited
Who may be able to join
- diagnosis of MS according to the latest revision of McDonald's criteria;
- patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (SPMS);
- absence of cortisone therapy for at least 6 months;
Who cannot join
- patients already being treated with anti-osteoporotic drugs;
- medical conditions that preclude the execution of the densitometric examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trabecular Bone Score (TBS) as an Innovative Parameter Evaluation for Bone Disease's in Multiple Sclerosis (MS) Patients and Impact of Osteoporosis on the Quality of Life of Patients With MS
Assess bone quality in MS patients through TBS and evaluate the potential effects exerted by different drugs used in MS treatment, which may affect BMD and TBS in MS patients
- Being tested
- sm tbs group
- Medical subject headings
- Multiple Sclerosis, Endocrine System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sm tbs groupDiagnostic test
After collecting anthropometric data, information on environmental factors and lifestyle (smoking, alcohol intake, physical activity, sun exposure, vitamin D supplementation, fish consumption) will be acquired through a questionnaire.
The genetic and environmental aspects related to multiple sclerosis will also be studied. Disability status will be assessed through the Kurtzke Extended Disability Status Scale (EDSS). [10] All recruited patients will be administered the questionnaire (Multiple Sclerosis Quality of Life-54 (MSQOL-54) composed of 14 scales and 54 items. The scales investigate physical functions, limitations with respect to physical and emotional role, pain, emotional well-being, degree of energy, perceptions of one's health, social, cognitive and sexual functioning, distress, changes in health, satisfaction with sexual functioning and quality of life in general.
| Study group | Role | What they receive |
|---|---|---|
| sm tbs group | All patients will undergo densitometric examination with dual-energy x-ray absorptiometry (DXA) technique at our Facility. Receives: Diagnostic Test: sm tbs group |
What is being measured
The primary outcome is the main question the study is designed to answer.
DXA scanner (Horizon© DXA System)
The DXA scanner (Horizon© DXA System) measures bone mineral content relative to bone area.
Measured: 6 months
Secondary outcomes (1)
Bone Mineral Density
BMD will be measured in the lumbar spine (L2-L4) and in the right and left femoral neck and trochanter regions.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start14 Feb 2021
- Primary completion20 Aug 2021
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811689
- Sponsor's protocol ID
- TBS SM2021
- Status last verified
- Feb 2021
- First submitted
- 17 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trabecular Bone Score (TBS) as an Innovative Parameter Evaluation for Bone Disease's in Multiple Sclerosis (MS) Patients and Impact of Osteoporosis on the Quality of Life of Patients With MS
- ClinicalTrials.gov ID
- NCT05811689
- Acronym / sponsor ID
- TBS SM2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 14 Feb 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 13 Apr 2023 (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.
Assess bone quality in MS patients through TBS and evaluate the potential effects exerted by different drugs used in MS treatment, which may affect BMD and TBS in MS patients
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sm tbs group | – | Diagnostic Test: sm tbs groupAll patients will undergo densitometric examination with dual-energy x-ray absorptiometry (DXA) technique at our Facility. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 subjects aged between 20 and 65, belonging to the MS Outpatient Clinic of the IRCCS Centro Neurolesi Bonino Pulejo will be recruited
Key inclusion criteria (3 listed)
- diagnosis of MS according to the latest revision of McDonald's criteria;
- patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (SPMS);
- absence of cortisone therapy for at least 6 months;
Key exclusion criteria (2 listed)
- patients already being treated with anti-osteoporotic drugs;
- medical conditions that preclude the execution of the densitometric examination
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 |
|---|---|---|
| sm tbs groupAfter collecting anthropometric data, information on environmental factors and lifestyle (smoking, alcohol intake, physical activity, sun exposure, vitamin D supplementation, fish consumption) will be acquired through a questionnaire. The genetic and environmental aspects related to multiple sclerosis will also be studied. Disability status will be assessed through the Kurtzke Extended Disability Status Scale (EDSS). [10] All recruited patients will be administered the questionnaire (Multiple Sclerosis Quality of Life-54 (MSQOL-54) composed of 14 scales and 54 items. The scales investigate physical functions, limitations with respect to physical and emotional role, pain, emotional well-being, degree of energy, perceptions of one's health, social, cognitive and sexual functioning, distress, changes in health, satisfaction with sexual functioning and quality of life in general. | Diagnostic test | sm tbs group |
Primary outcome
DXA scanner (Horizon© DXA System)
Time frame: 6 months
The DXA scanner (Horizon© DXA System) measures bone mineral content relative to bone area.
1 secondary outcome
Bone Mineral Density
Time frame: 6 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 13 Apr 2023.
- Individual participant dataSharing planned: Undecided. corresponding author
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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 Multiple Sclerosis and Endocrine System Diseases, run by IRCCS Centro Neurolesi Bonino Pulejo 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 2 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 13 Apr 2023. 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?
DXA scanner (Horizon© DXA System) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2023.