An interventional study of Bone densitometry scan in Bone Density, sponsored by Centre Hospitalier Universitaire de Nīmes. Not yet recruiting at 2 sites in France. Open to female participants aged 20 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Health services research
Up-to-date normalcy curves for bone mineral density and body composition (fat and lean mass), are currently lacking. DMS IMAGING is therefore financing the MONIKA study, with Nîmes University Hospital as sponsor.
Some 425 healthy female volunteers aged 20 to 89 will be recruited from three centers (Nîmes, Montpellier and Lyon). A bone density scan at various bone sites (femur, rachis, radius and whole body) will provide up-to-date normalcy curves for bone mineral density as well as body composition (fat and lean mass). These measurements should help to better understand bone physiology and the links that may exist between bone tissue and muscle and adipose tissue.
This is a prospective multicenter cross-sectional descriptive study of healthy female volunteers. The study population is made up of healthy female volunteers from Europe, the Middle East and North Africa aged between 20 and 89, stratified into 7 age groups.
Bone densitometry using dual-photon X-ray absorptiometry (DXA) is the standard technique for measuring bone mineral density. According to the International Osteoporosis Foundation (IOF), if a single site is to be preferred, it should be the total hip or femoral neck, using a single NHANES III reference curve. It should be stressed, however, that this curve was obtained from a North American population with anthropometric parameters, notably body mass index (BMI), that differ from those of European populations, and more particularly of European, Middle Eastern and North African origin.
So far, only one reference curve has been obtained in France, from the OFELY study in 1993.
Given the age of this cohort and the possibility of changes in BMI over time in the population of European, Middle Eastern and North African origin, but even more so, the impossibility of transposing this curve onto new DXAs of different brands, new reference curves need to be developed. DMS IMAGING is therefore financing the MONIKA study, with Nîmes University Hospital as sponsor.
As part of this study, some 425 healthy female volunteers aged between 20 and 89 will be recruited from three centers (Nîmes, Montpellier, Lyon). A DXA examination at various bone sites (femur, rachis, radius and whole body) will provide up-to-date normalcy curves for BMD, but also for body composition (fat and lean mass), which are currently lacking. Access to this population could also enable us to better understand bone physiology and the links that may exist between bone tissue and muscle and adipose tissue.
Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 594 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
All patients on any treatment that may affect bone mass or body composition:
All patients with one of the following anomalies in the measurement area:
Miscellaneous :
This group will be used to construct the T-score equation, and thus define the thresholds for osteopenia and osteoporosis. To ensure adequate precision for this T-score, 175 subjects will be included in this age group. With this number of subjects, the following accuracies for two of the sites of interest (hip and L1-L4) are expected: For the hip, the expected bone mineral density value is 0.95 (SD=0.11) according to local data consistent with Arlot et al. Inclusion of 175 subjects would give a ½ width 95% confidence interval (IC95%) of the mean would be around 0.016, and the half width standard deviation of 0.012 For L1-L4, the expected bone mineral density value is 0.99 (SD=0.11) according to local data consistent with Arlot et al. The ½ width of the 95% confidence interval (IC95%) of the mean would be around 0.016, and the half-width standard deviation of 0.012.
Radiation: Bone densitometry scan
For the 30-39 age group, only 25 subjects will be included, given the constancy of bone mineral density in this age group compared with the 20-29 age group. In addition, the results of the analyses will take the form of a Z-score equation, estimated using a regression method (i.e. overall and not a z-score per age group). As there will be many subjects under 30 and over 40, this will ensure (by interpolation) an equivalent precision in these age brackets to that of the adjacent age categories.
Radiation: Bone densitometry scan
Group including 50 subjects.
Radiation: Bone densitometry scan
Group including 50 subjects.
Radiation: Bone densitometry scan
Group including 50 subjects.
Radiation: Bone densitometry scan
Group including 50 subjects.
Radiation: Bone densitometry scan
Only 25 subjects will be included in this age group for reasons of feasibility.
Radiation: Bone densitometry scan
Each study participant will undergo a bone density measurement scan. The equipment used in this study will be the STRATOS DR X-ray bone densitometer (APELEM, 9 Avenue du Canal Philippe Lamour, 30660 Gallargues-le-Montueux, France). This device is indicated for diagnosing osteoporosis, assessing the risk of fracture in weakened bone areas, monitoring bone density, monitoring body composition and diagnosing vertebral anomalies (vertebral compression, fractures). In general, the time for a scan is less than 1 min for the spine, less than than 1 min for the femur, less than 1 min for the forearm and around 4 min for the whole body. The total duration of the patient's participation in this research will be approximately 2 hours.
Also known as: Dual-energy X-ray absorptiometry (DEXA or DXA)
Bone mineral density of the femoral neck: Left side
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Time frame: Day 0, day of inclusion
Bone mineral density of the femoral neck: Right side
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Time frame: Day 0, day of inclusion
Bone mineral density of the femoral neck: Lumbar spine (L1 - L4)
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Time frame: Day 0, day of inclusion
Bone mineral density of the femoral neck: Forearm
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Time frame: Day 0, day of inclusion
Bone mineral density of the femoral neck: Whole body
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Time frame: Day 0, day of inclusion
Percentage body fat: left hip
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Time frame: Day 0, day of inclusion
Body fat: left hip
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Time frame: Day 0, day of inclusion
Percentage body fat: right hip
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Time frame: Day 0, day of inclusion
Body fat: right hip
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Time frame: Day 0, day of inclusion
Muscle mass: left hip
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Time frame: Day 0, day of inclusion
Muscle mass: right hip
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Time frame: Day 0, day of inclusion
Percentage body fat in the region of the lumbar spine (L1 - L4)
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Time frame: Day 0, day of inclusion
Body fat in the region of the lumbar spine (L1 - L4)
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Time frame: Day 0, day of inclusion
Muscle mass in the region of the lumbar spine (L1 - L4)
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Time frame: Day 0, day of inclusion
Percentage body fat: forearm
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Time frame: Day 0, day of inclusion
Body fat: forearm
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Time frame: Day 0, day of inclusion
Muscle mass: forearm
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Time frame: Day 0, day of inclusion
Percentage body fat: whole body
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Time frame: Day 0, day of inclusion
Body fat: whole body
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Time frame: Day 0, day of inclusion
Muscle mass: whole body
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Time frame: Day 0, day of inclusion
Weight of participants
The weight of each participant will be recorded in kg
Time frame: Day 0, day of inclusion
Height of participants
The height of each participant will be recorded in cm
Time frame: Day 0, day of inclusion
Body Mass Index of participants
The body mass index (BMI) of each participant will be calculated as follows : BMI = weight \[kg\] / height 2 \[m2\]
Time frame: Day 0, day of inclusion
Plan to share: No — All data will be managed by the BESPIM (Biostatistics, Epidemiology, Public Health \& Innovations in Methodology, Nîmes University Hospital). The conditions for the transfer of all or part of the research database are decided by the research sponsor and are the subject of a written contract.
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Start is estimated for Jun 2025; primary completion for Sep 2029, 51 months later.
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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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