NCT07030205

Resting-state Imaging and OSteoporosiS

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
OTHER	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)).
OTHER	Bone density exam	A bone density exam will be performed in order to verify the non-osteoporotic status of the healthy volunteers group.
OTHER	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).
OTHER	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-06-22
• Last updated: 2025-06-22

Locations

1 site across 1 country: France