Trabecular Bone Score in Multiple Sclerosis

March 31, 2023 updated by: IRCCS Centro Neurolesi "Bonino-Pulejo"

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Messina, Italy, 98149
        • IRCCS Centro Neurolesi Bonino Pulejo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

patients already being treated with anti-osteoporotic drugs;

• medical conditions that preclude the execution of the densitometric examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
sm tbs group
All patients will undergo densitometric examination with dual-energy x-ray absorptiometry (DXA) technique at our Facility.
Diagnostic test: sm tbs group

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DXA scanner (Horizon© DXA System)
Time Frame: 6 months
The DXA scanner (Horizon© DXA System) measures bone mineral content relative to bone area.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density
Time Frame: 6 months
BMD will be measured in the lumbar spine (L2-L4) and in the right and left femoral neck and trochanter regions.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
TBS iNsight™ Hologic
Time Frame: 6 months
A software application, the TBS iNsight™ Hologic, the analysis of the structure of the bone matrix will be carried out, in order to evaluate the quantity and quality of the microarchitecture.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2021

Primary Completion (Actual)

August 20, 2021

Study Completion (Actual)

February 15, 2023

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBS SM2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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