Resting-state brain imaging in postmenopausal osteoporosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.