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Trabecular Bone Score in Multiple Sclerosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05811689
Enrollment
300
Registered
2023-04-13
Start date
2021-02-14
Completion date
2023-02-15
Last updated
2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocrine System Diseases, Multiple Sclerosis, Neurologic Disorder

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

Interventions

DIAGNOSTIC_TESTsm 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.

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DXA scanner (Horizon© DXA System)6 monthsThe DXA scanner (Horizon© DXA System) measures bone mineral content relative to bone area.

Secondary

MeasureTime frameDescription
Bone Mineral Density6 monthsBMD will be measured in the lumbar spine (L2-L4) and in the right and left femoral neck and trochanter regions.

Other

MeasureTime frameDescription
TBS iNsight™ Hologic6 monthsA 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026