Trabecular Bone Score in Multiple Sclerosis
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- DXA scanner (Horizon© DXA System) [6 months]
The DXA scanner (Horizon© DXA System) measures bone mineral content relative to bone area.
Secondary Outcome Measures
- Bone Mineral Density [6 months]
BMD will be measured in the lumbar spine (L2-L4) and in the right and left femoral neck and trochanter regions.
Other Outcome Measures
- TBS iNsight™ Hologic [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Centro Neurolesi Bonino Pulejo | Messina | Italy | 98149 |
Sponsors and Collaborators
- IRCCS Centro Neurolesi "Bonino-Pulejo"
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TBS SM2021