Resting-state Imaging and OSteoporosiS

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how different areas of the brain communicate with each other in women who have osteoporosis, a condition that weakens bones, especially after menopause. The study will include three groups of women: those who are healthy and postmenopausal, those with osteoporosis who have had a bone fracture, and those with osteoporosis without a fracture. Researchers want to understand if and how brain function might be linked to osteoporosis and fractures by using a special type of brain scan called resting-state functional MRI (rs-fMRI). Participants will also complete questionnaires and tests to check their thinking skills, quality of life, sleep, physical activity, pain, anxiety, and mood. A small biological sample will be taken to look at markers related to bone health.

Women who are 50 years or older and postmenopausal may be eligible to participate. Those with osteoporosis must have a diagnosis from their doctor, and healthy volunteers should not have osteoporosis based on a bone density test done as part of the study. All participants need to be able to give informed consent and be affiliated with French Social Security. The study excludes women with certain medical devices like pacemakers or those who cannot safely have an MRI scan. If you take part, you can expect to undergo brain imaging, answer questions about your health and lifestyle, and provide a small biological sample. This research is not yet recruiting but aims to better understand how brain activity relates to osteoporosis, which could help improve care in the future.

Gender

FEMALE

Eligibility 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