Resting-state brain imaging in postmenopausal osteoporosis
Resting-state Imaging and OSteoporosiS
This project will use resting-state MRI scans, questionnaires, bone density testing, and blood tests to see if brain connectivity and bone-remodeling markers differ between postmenopausal women with osteoporosis (with and without fractures) and matched healthy postmenopausal volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT07030205 on ClinicalTrials.gov |
What this trial studies
This interventional protocol enrolls three groups of 20 postmenopausal women each (healthy controls, osteoporotic with fracture, and osteoporotic without fracture) to compare functional connectivity across brain regions using resting-state fMRI. Participants will complete standardized questionnaires and tests covering cognition, quality of life, sleep, physical activity, pain, anxiety and depression, and will undergo bone density measurement and a blood draw for markers of bone remodeling. Resting-state fMRI data will be used to compute functional connectivity values for brain networks at rest and these measures will be compared between groups and correlated with clinical, cognitive, and biological data. Inclusion requires being female, aged 50 or older, able to undergo MRI, able to give informed consent, and affiliated with French social security.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 50 or older with confirmed osteoporosis (with or without prior fracture) who can undergo MRI and have French social security coverage.
Not a fit: Women who have MRI-incompatible devices (e.g., pacemakers, certain implants), who cannot give informed consent, or who lack French social security would not be eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the project could reveal brain connectivity or blood marker patterns linked to fracture risk or symptoms in postmenopausal osteoporosis, which might help guide earlier or more tailored care.
How similar studies have performed: Applying resting-state fMRI to osteoporosis is relatively novel—prior small studies have suggested links between bone health, cognition, and brain changes, but direct comparisons of connectivity in fractured versus nonfractured osteoporotic patients remain exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clermont-Ferrand
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Marie-Eva Pickering — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.