Resting-state Imaging and OSteoporosiS

NCT07030205 | Recruiting

• 2 other identifiers: RBHP 2025 PICKERING_ME2025-A00106-43
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis

Keywords

Osteoporosis; Resting state fMRI (rs-fMRI); Cognition

Outcome Measures

Primary Outcomes (1)

• Functional connectivity value of brain networks at rest

  The primary outcome is the functional connectivity value of brain networks at rest, calculated from resting-state fMRI data.

  At visit 2 (end of study visit, up to fifteen days after inclusion) for osteoporotic patient group and at visit 3 (end of study visit, up to one month after inclusion) for healthy volunteers group.

Secondary Outcomes (23)

• Evaluation of cognitive function (MoCA test)

  At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.

• Evaluation of cognitive function (Cantab test: MOT)

  At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.

• Evaluation of cognitive function (CANTAB test: Reaction Time (RTI)

  At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.

• Evaluation of cognitive function (CANTAB test: Digit Span)

  At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.

• Evaluation of cognitive function (CANTAB test: Match to Sample Visual Search)

  At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.

Study Arms (3)

Postmenopausal Healthy volunteers

EXPERIMENTAL

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

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

Postmenopausal osteoporotic patients with fracture

EXPERIMENTAL

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

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

Postmenopausal osteoporotic patient without fracture

EXPERIMENTAL

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

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

Interventions

Blood sample OTHER

A blood sample (fasting), for biobanking purposes to measure certain bone biological markers known to be indicators of bone remodeling (osteocalcin, sclerostin, periostin, irisin, procollagen type 1 N-terminal propeptide (P1NP), Dickkopf-related protein 1 (DKK1), and collagen type 1 C-terminal telopeptides (CTX)).

Postmenopausal Healthy volunteers; Postmenopausal osteoporotic patient without fracture; Postmenopausal osteoporotic patients with fracture

Bone density exam OTHER

A bone density exam will be performed in order to verify the non-osteoporotic status of the healthy volunteers group.

Postmenopausal Healthy volunteers

Tests and questionnaires of study OTHER

An assessment of cognitive functions will be realized using Montreal Cognitive Assessment (MoCA), Cantab® tests (MOT, MTS, RTI, DGS), the Trail Making Test (TMT), verbal fluency, the Stroop test, the Dubois 5-word test, and the oral picture naming test. Other questionnaires will be used, assessing: sleep quality (Pittsburgh Physical Activity Questionnaire (PSQI)), anxiety and depression (the anxiety/depression scale (HAD)), quality of life (Short Form-36 quality of life questionnaire (SF-36)), physical activity (International Physical Activity Questionnaire (IPAQ)), and pain with the Brief Pain Inventory questionnaire (BPI) and the numerical scale (EN).

Postmenopausal Healthy volunteers; Postmenopausal osteoporotic patient without fracture; Postmenopausal osteoporotic patients with fracture

Functional connectivity value of brain networks at rest OTHER

A Resting-State Functional Magnetic Resonance Imaging will be conducted in order to evaluate and compared functional connectivity value of brain networks at rest between three groups.

Postmenopausal Healthy volunteers; Postmenopausal osteoporotic patient without fracture; Postmenopausal osteoporotic patients with fracture

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marie-Eva Pickering

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient will have two visits : Visit 1 - Inclusion visit (informed consent, medical examination, stool sample and test/questionnaires assessing cognition, pain, physical activity, sleep, quality of life, anxiety and depression). -Visit 2 - End of study visit During this visit, a resting-State Functional Magnetic Resonance Imaging will be conducted. Postmenopausal healthy volunteers will have three visits : Visit 1 - Inclusion visit (informed consent, medical examination and bone density test) Visit 2 : stool sample and test/questionnaires assessing cognition, pain, physical activity, sleep, quality of life, anxiety and depression) -Visit 3 - End of study visit During this visit, a resting-State Functional Magnetic Resonance Imaging will be conducted.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)