Resting-state Imaging and OSteoporosiS
ConditionOsteoporosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Blood sample
Other interventionA 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)).
Bone density exam
Other interventionA bone density exam will be performed in order to verify the non-osteoporotic status of the healthy volunteers group.
Tests and questionnaires of study
Other interventionAn 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).
Functional connectivity value of brain networks at rest
Other interventionA 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.
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Postmenopausal Healthy volunteersExperimental treatment 4 interventions
Group B: Postmenopausal osteoporotic patients with fractureExperimental treatment 3 interventions
Group C: Postmenopausal osteoporotic patient without fractureExperimental treatment 3 interventions
Trial outcomes
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.
Time frame
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
1
Evaluation of cognitive function (MoCA test)
The Montreal Cognitive Assessment (MoCA) is the most sensitive rapid assessment test, with the broadest range of cognitive functions (attention, concentration, executive functions, memory, language, visuo-constructive abilities, abstraction, calculation, orientation). Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Time frame
At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.2
Evaluation of cognitive function (Cantab test: MOT)
The Motor Screening Task provides a general assessment of whether sensorimotor deficits or lack of comprehension, will limit the collection of valid data from the participant. Coloured crosses are presented in different locations on the screen, one at a time. The participant must select the cross on the screen as quickly and accurately as possible. Outcome measures cover accuracy (Euclidean distance between finger and target) and difficulty speed adjustment.
Time frame
At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.3
Evaluation of cognitive function (CANTAB test: Reaction Time (RTI)
Reaction Time provides assessments of motor and mental response speeds, as well as measures of movement time, reaction time, response accuracy and impulsivity. The participant must select and hold a button at the bottom of the screen. Circles are presented above (one for the simple mode, and five for the five-choice mode). In each case, a yellow dot will appear in one of the circles, and the participant must react as soon as possible, releasing the button at the bottom of the screen, and selecting the circle in which the dot appeared. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants.
Time frame
At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.4
Evaluation of cognitive function (CANTAB test: Digit Span)
Digit Span (DGS) is a measure of verbal short term and working memory. The participant will hear a sequence of digits and then immediately be prompted to verbally repeat the sequence, either as it was heard (forwards), or in reverse order (backwards). If the participant responds correctly, the next trial presents a longer sequence. The task terminates when participants responded incorrectly on three occasions at a span length. The participant's span is the longest number of sequential digits that can accurately be remembered. Outcome measures include the direction of the task (forwards or backwards), the longest sequence successfully reached and passed, and the total number of attempts.
Time frame
At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.Sponsors and contacts
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Source ClinicalTrials.gov