Trabecular Bone Score in Multiple Sclerosis

NCT ID: NCT05811689

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-14

Study Completion Date

2023-02-15

Brief Summary

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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

Detailed Description

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Conditions

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Multiple Sclerosis Endocrine System Diseases Neurologic Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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sm tbs group

All patients will undergo densitometric examination with dual-energy x-ray absorptiometry (DXA) technique at our Facility.

sm tbs group

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Centro Neurolesi Bonino Pulejo

Messina, , Italy

Site Status

Countries

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Italy

Other Identifiers

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TBS SM2021

Identifier Type: -

Identifier Source: org_study_id

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