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Completed

NCT Number: NCT05811689

Trabecular Bone Score in Multiple Sclerosis

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Endocrine System Diseases Immune System Diseases Nervous System Diseases Neurologic Disorder

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Centro Neurolesi Bonino Pulejo

Messina, 98149, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sm tbs group

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.

Primary outcomes

  1. DXA scanner (Horizon© DXA System)

    Time frame: 6 months

    The DXA scanner (Horizon© DXA System) measures bone mineral content relative to bone area.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Apr 13, 2023
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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