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OsteoporosisROSSNCT07030205

Resting-state Imaging and OSteoporosiS

A study testing Blood sample, Bone density exam and Tests and questionnaires of study in people with Osteoporosis, run by University Hospital, Clermont-Ferrand at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Osteoporosis
What is being tested?
Blood sample, Bone density exam and Tests and questionnaires of study
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteFrance
Study dates
3 Sep 2025to 1 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 9Show fewer
  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • CHU de Clermont-Ferrand

    Clermont-Ferrand

    Lise Laclautre

    Marie-Eva Pickering

    Recruiting

Other trials in France

About this study

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
Being tested
Blood sample, Bone density exam, Tests and questionnaires of study, Functional connectivity value of brain networks at rest
Keywords
Osteoporosis, Resting state fMRI (rs-fMRI), Cognition
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleOther

    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)).

  • Bone density examOther

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

  • Tests and questionnaires of studyOther

    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).

  • Functional connectivity value of brain networks at restOther

    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.

Study groups in NCT07030205
Study groupRoleWhat they receive
Postmenopausal Healthy volunteersExperimental22 postmenopausal healthy women, matched by age, menopausal status, socio-educational level and manual laterality, will be included in this study
Receives: 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 fractureExperimental22 Postmenopausal osteoporosis patients with fractures will be included in this study
Receives: Other: Blood sample; Other: Tests and questionnaires of study; Other: Functional connectivity value of brain networks at rest
Postmenopausal osteoporotic patient without fractureExperimental22 Postmenopausal osteoporosis patients without fractures will be included in this study.
Receives: Other: Blood sample; Other: Tests and questionnaires of study; Other: Functional connectivity value of brain networks at rest

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

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

    Match to Sample Visual Search assesses attention and visual searching, with a speed accuracy trade-off. The participant is shown a complex visual pattern in the middle of the screen. After a brief delay, a varying number of similar patterns are shown in a circle of boxes around the edge of the screen. Only one of these patterns matches the pattern in the centre of the screen, and the participant must indicate which it is by selecting it. The outcome measures for this task cover accuracy and reaction time.

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

  6. Evaluation of cognitive function (Trail Making Test)

    The Trail Making Test is a neuropsychological test of visual attention and task switching. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. There are 2 parts to the TMT. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); The subject must correctly connect the circles as quickly as possible, within a limit of 100 seconds for part A and 300 seconds for part B. For each part, the completion time and the number of errors are collected.

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

  7. Evaluation of cognitive function (Stroop test)

    The Stroop Color Test assesses selective attention and the ability to inhibit cognitive interference, which occurs when the processing of one feature of a stimulus affects the simultaneous processing of another feature of the same stimulus. This test consists of three conditions:

    1. Color Naming (the instruction is to name the color of green, red, and blue squares),
    2. Reading "color name" words (the words "red," "blue," and "green" are printed in black),
    3. Interference (the instruction is to name the ink color of the "color name" words, printed in a different ink color-for example, the word "blue" is printed in red).

    For each condition, a sheet of 50 items is presented to the participant, and the total time is recorded (within a limit of 90 seconds for Conditions 1 and 2, and 180 seconds for Condition 3), as well as the number of corrected and uncorrected errors.

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

  8. Evaluation of cognitive function (Verbal fluency test)

    Verbal fluency is used to assess executive functions. This test is a simple language production test. This test assesses semantic fluency or categorical fluency. This is done by asking the participant to name as many nouns as possible in a given category in two minutes. Words from the same family and proper nouns should not be mentioned, and the participant should not repeat themselves. A score will be calculated based on the number of words given and the number of errors made.

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

  9. Evaluation of cognitive function (5 words test)

    The 5-word test is divided into two different stages. The first allows us to check the encoding of the information to be remembered. To do this, the subject will be shown a list of 5 words that they will have to read aloud and remember. To ensure memorization, the subject will be immediately questioned about the words they have just remembered. If necessary, clues may be provided. Once this first stage is completed, an intercurrent attentional test will be carried out. Its purpose is to divert the subject's attention for a sufficient time (between 3 and 5 minutes). At the end of the intercurrent test, the participant is again asked for the 5 words they previously remembered. Once again, clues may be provided if necessary. The data collected are the scores for immediate recall and delayed recall, with and without cueing.

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

  10. Evaluation of cognitive function (Oral Picture Naming Test)

    The oral picture naming test highlights the extent of the patient's potential word deficit and provides valuable insights into the process of impaired speech when analyzing the nature of the errors. During this test, the subject will be presented with cards representing objects. The subject must name the object presented. In this study, 20 cards will be presented to the participants. The data collected include the number of correctly named images and the type of errors.

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

  11. The Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a self-administered questionnaire with 19 items. It was developed to measure sleep quality in the month prior to the patient interview. This questionnaire includes 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, hypnotic medication use and daytime dysfunction.

    The global score (0 to 21) is obtained by adding the sub-scores of the 7 components, each ranging from 0 to 3 points. In the absence of an answer to one or more questions, the subtotal using this question cannot be calculated and will affect the overall score.

    The higher the overall score, the greater the impairment in sleep quality. An overall score >5 is an indicator of sleep disturbance.

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

  12. Evaluation of pain: The Brief Pain Inventory Questionnaire (BPI)

    This self-assessment scale allows the patient to characterize the pain in terms of its intensity and its psychosocial repercussions by means of 11 scales rated from 0 (no pain or does not bother) to 10 (the most horrible pain you can imagine or completely bothers you).

    The BPI also asks the patient to black out the painful areas on a diagram (front and back) and to put an "S" if the pain is on the surface or a "P" if it is deep. The questionnaire also asks the patient to indicate what treatment or medication he or she is taking for the pain and what percentage improvement has been obtained.

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

  13. Evaluation of pain: Numerical pain scale

    This scale allows the patient to rate the pain on a scale with a minimum score of 0 (no pain) and a maximum score of 10 (worst pain).

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

  14. Evaluation of quality of life: The 36-Item Short Form Survey (SF-36)

    The quality of life of patients is assessed by the general questionnaire 36-Item Short Form Survey (SF-36) which can be administered by self or hetero-questionnaire. The SF-36 questionnaire was developed from the Medical Outcome Study, a 149-item questionnaire that was developed to assess how the American healthcare system affects the outcome of care. The SF-36 questionnaire is composed of 36 items and makes it possible to assess the physical and mental health of an individual using eleven questions relating to eight aspects of health: Physical activity, limitations due to physical state, physical pain, perceived health, vitality, life and relationship with others, limitations due to the mental state and mental health. Scores between 0 and 100 are determined. Scores tending towards 100 indicate a better quality of life.

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

  15. Evaluation of anxiety and depression: The Hospital Anxiety and Depression Scale (HAD)

    It is a self-administered questionnaire completed by the patient and based on the Hamilton scale. The HAD scale is a tool for screening for anxiety and depressive disorders. It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21).

    To screen for anxiety and depressive symptomatology, the following interpretation can be proposed for each of the scores (A and D): ≤ 7: normal case; 8 to 10: borderline case; ≥ 11: abnormal case.

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

  16. Evaluation of physical activity: International Physical Activity Questionnaire - Short Form

    IPAQ assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening (yard) activities, work-related and transport-related activity; The IPAQ short form asks about three specific types of activity undertaken in the three domains introduced above and sitting. The specific types of activity that are assessed are walking, moderate-intensity activities and vigorous intensity activities; frequency (measured in days per week) and duration (time per day) are collected separately for each specific type of activity. The items were structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activity.

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

  17. Sclerostin dosage

    The dosage of sclerostin (pg/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes.

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

  18. Osteocalcin dosage

    The dosage of osteocalcin (µg/L) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 6 mL EDTA tube.

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

  19. Periostin dosage

    The dosage of periostin (pg/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes.

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

  20. Irisin dosage

    The dosage of irisin (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken on 4 mL heparin tube for irisin dosage.

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

  21. N-terminal propeptide of procollagen type 1 dosage

    The dosage of N-terminal propeptide of procollagen type 1 (P1NP) (µg/l) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes

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

  22. Dickkopf-related protein 1 dosage

    The dosage of Dickkopf-related protein 1 (pg/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 5 mL dry tubes

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

  23. C-terminal telopeptides of collagen type 1 dosage

    The dosage of C-terminal telopeptides of collagen type 1 (CTX) (ng/ml) will be performed in order to evaluate bone remodeling. For this purpose, a blood sample will be taken using 6 mL EDTA tube.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study start3 Sep 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07030205
Sponsor's protocol ID
RBHP 2025 PICKERING_ME
Other IDs
2025-A00106-43
Acronym
ROSS
Status last verified
Jun 2025
First submitted
12 Jun 2025
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample, Bone density exam and Tests and questionnaires of study in people with Osteoporosis, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional connectivity value of brain networks at rest (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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