Resting-state Imaging and OSteoporosiS

Обзор

This study will be conducted in 20 postmenopausal healthy volunteers, 20 postmenopausal osteoporotic patients with fracture and 20 postmenopausal osteoporotic women without fracture, in order to compare functional connectivity between brain areas. Participants will complete different questionnaires and tests assessing cognition, quality of life, sleep, physical activity, pain, anxiety and depression. A biological sample will be performed in order to evaluate different markers of bone remodeling. A Resting-state functional magnetic resonance imaging (rs-fMRI) will be realized in order to establish functional connectivity between brain regions.

Вмешательства

• Другое Blood sample
  A blood sample (fasting), for biobanking purposes to measure certain bone biological markers known to be indicators of bone remodeling (osteocalcin, sclerostin, periostin, irisin, procollagen type 1 N-terminal propeptide (P1NP), Dickkopf-related protein 1 (DKK1), and collagen type 1 C-terminal telopeptides (CTX)).
• Другое Bone density exam
  A bone density exam will be performed in order to verify the non-osteoporotic status of the healthy volunteers group.
• Другое Tests and questionnaires of study
  An assessment of cognitive functions will be realized using Montreal Cognitive Assessment (MoCA), Cantab® tests (MOT, MTS, RTI, DGS), the Trail Making Test (TMT), verbal fluency, the Stroop test, the Dubois 5-word test, and the oral picture naming test. Other questionnaires will be used, assessing: sleep quality (Pittsburgh Physical Activity Questionnaire (PSQI)), anxiety and depression (the anxiety/depression scale (HAD)), quality of life (Short Form-36 quality of life questionnaire (SF-36)), p
• Другое Functional connectivity value of brain networks at rest
  A Resting-State Functional Magnetic Resonance Imaging will be conducted in order to evaluate and compared functional connectivity value of brain networks at rest between three groups.

Первичные конечные точки

• Functional connectivity value of brain networks at rest [Срок оценки: At visit 2 (end of study visit, up to fifteen days after inclusion) for osteoporotic patient group and at visit 3 (end of study visit, up to one month after inclusion) for healthy volunteers group.]

Вторичные конечные точки (12)

• Evaluation of cognitive function (MoCA test) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• Evaluation of cognitive function (Cantab test: MOT) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• Evaluation of cognitive function (CANTAB test: Reaction Time (RTI) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• Evaluation of cognitive function (CANTAB test: Digit Span) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• Evaluation of cognitive function (CANTAB test: Match to Sample Visual Search) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• Evaluation of cognitive function (Trail Making Test) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• Evaluation of cognitive function (Stroop test) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• Evaluation of cognitive function (Verbal fluency test) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• Evaluation of cognitive function (5 words test) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• Evaluation of cognitive function (Oral Picture Naming Test) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]
• Evaluation of pain: The Brief Pain Inventory Questionnaire (BPI) [Срок оценки: At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.]

Критерии участия

Inclusion Criteria (patients):

• Women aged 50 or over, with postmenopausal osteoporosis, fractured or not, diagnosed by their rheumatologist,
• Able to give informed consent to participate in the research,
• Affiliation with the French Social Security.

Inclusion Criteria (healthy volunteers):

• Women aged 50 or over,
• Bone densitometry performed as part of the protocol, not suggestive of osteoporosis and validated by investigators,
• Matched to patients by age, menopausal status, socio-educational level and manual laterality,
• Able to give informed consent to participate in the research,
• Affiliation with the French Social Security.
• Registration or acceptance of registration in the national register of volunteers participating in Research.

Exclusion Criteria (patient and healthy volunteers):

• Presence of pacemaker,
• Presence of medical devices (implants or prostheses),
• Incompatibility of the patient with the safety criteria of the medical imaging center for carrying out magnetic resonance experiments at 3 Tesla,
• Contraindications to the realization of MRI without injection such as claustrophobia proven, hearing aid, pacemaker wearers, wearing a brain clip,
• Refusal to be informed in the event of the accidental discovery of an anomaly during the resting state functional magnetic resonance imaging,
• Woman under legal protection or deprived of liberty,
• Refusal to participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU de Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT07030205 · RBHP 2025 PICKERING_ME · 2025-A00106-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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