Trabecular Bone Score in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05811689
• Other study ID #: TBS SM2021
• Status: Completed
• Start date: February 14, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2021
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 15, 2023
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Endocrine System Diseases
• Multiple Sclerosis
• Nervous System Diseases
• Neurologic Disorder
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi Bonino Pulejo	Messina

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TBS iNsight™ Hologic	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
Primary	DXA scanner (Horizon© DXA System)	The DXA scanner (Horizon© DXA System) measures bone mineral content relative to bone area.	6 months
Secondary	Bone Mineral Density	BMD will be measured in the lumbar spine (L2-L4) and in the right and left femoral neck and trochanter regions.	6 months