Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2025-07-01
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Visit 1 - Inclusion visit (informed consent, medical examination, stool sample and test/questionnaires assessing cognition, pain, physical activity, sleep, quality of life, anxiety and depression).
-Visit 2 - End of study visit During this visit, a resting-State Functional Magnetic Resonance Imaging will be conducted.
Postmenopausal healthy volunteers will have three visits :
Visit 1 - Inclusion visit (informed consent, medical examination and bone density test) Visit 2 : stool sample and test/questionnaires assessing cognition, pain, physical activity, sleep, quality of life, anxiety and depression)
-Visit 3 - End of study visit During this visit, a resting-State Functional Magnetic Resonance Imaging will be conducted.
OTHER
NONE
Study Groups
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Postmenopausal Healthy volunteers
22 postmenopausal healthy women, matched by age, menopausal status, socio-educational level and manual laterality, will be included in this study
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)).
Bone density exam
A bone density exam will be performed in order to verify the non-osteoporotic status of the healthy volunteers group.
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)), physical activity (International Physical Activity Questionnaire (IPAQ)), and pain with the Brief Pain Inventory questionnaire (BPI) and the numerical scale (EN).
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.
Postmenopausal osteoporotic patients with fracture
22 Postmenopausal osteoporosis patients with fractures will be included in this study
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)).
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)), physical activity (International Physical Activity Questionnaire (IPAQ)), and pain with the Brief Pain Inventory questionnaire (BPI) and the numerical scale (EN).
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.
Postmenopausal osteoporotic patient without fracture
22 Postmenopausal osteoporosis patients without fractures will be included in this study.
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)).
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)), physical activity (International Physical Activity Questionnaire (IPAQ)), and pain with the Brief Pain Inventory questionnaire (BPI) and the numerical scale (EN).
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.
Interventions
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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)).
Bone density exam
A bone density exam will be performed in order to verify the non-osteoporotic status of the healthy volunteers group.
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)), physical activity (International Physical Activity Questionnaire (IPAQ)), and pain with the Brief Pain Inventory questionnaire (BPI) and the numerical scale (EN).
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.
Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent to participate in the research,
* Affiliation with the French Social Security.
* 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
* 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
50 Years
FEMALE
Yes
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Marie-Eva Pickering
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Lise Laclautre
Role: primary
Other Identifiers
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2025-A00106-43
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP 2025 PICKERING_ME
Identifier Type: -
Identifier Source: org_study_id
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