Resting-state Imaging and OSteoporosiS
Recruiting · NCT07030205 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Clermont-Ferrand
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- CHU de Clermont-Ferrand - Clermont-Ferrand, France