Resting-state Imaging and OSteoporosiS
University Hospital, Clermont-Ferrand
66 participants
Sep 3, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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.
- 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 Criteria7
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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)).
A bone density exam will be performed in order to verify the non-osteoporotic status of the healthy volunteers group.
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).
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07030205