Resting-state Imaging and OSteoporosiS (ROSS)

University Hospital, Clermont-Ferrand

Status: Not yet enrolling

Conditions: Osteoporosis

Treatments: Other: Functional connectivity value of brain networks at rest; Other: Bone density exam; Other: Blood sample; Other: Tests and questionnaires of study

Study type: Interventional

Funder types: Other

Identifiers

NCT07030205

2025-A00106-43 (Other Identifier)

RBHP 2025 PICKERING_ME

Details and patient eligibility

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.

Enrollment: 66 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Postmenopausal Healthy volunteers

Experimental group

Description:

22 postmenopausal healthy women, matched by age, menopausal status, socio-educational level and manual laterality, will be included in this study

Treatment:

Other: Tests and questionnaires of study

Other: Blood sample

Other: Bone density exam

Other: Functional connectivity value of brain networks at rest

Postmenopausal osteoporotic patients with fracture

Experimental group

Description:

22 Postmenopausal osteoporosis patients with fractures will be included in this study

Treatment:

Other: Tests and questionnaires of study

Other: Blood sample

Other: Functional connectivity value of brain networks at rest

Postmenopausal osteoporotic patient without fracture

Experimental group

Description:

22 Postmenopausal osteoporosis patients without fractures will be included in this study.

Treatment:

Other: Tests and questionnaires of study

Other: Blood sample

Other: Functional connectivity value of brain networks at rest