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.
Ethnic origin European, Middle Eastern, North African and whose 2 parents are from Europe, Middle East, North Africa only as there is a difference in BMD according to ethnicity
Person affiliated to or benefiting from a social security scheme
Free, informed consent signed by the participant and the investigator (on the day of inclusion and before any examination required by the research).
Fragility fracture defined as a spontaneous or low-kinetic fracture (≤ one fall from height)
Hip fracture in a first-degree relative
Early menopause (< age 40), Hysterectomy (complete < age 40), Primary amenorrhea (absence of menstruation before age 15), Current amenorrhea of more than 3 months without contraceptive if patient is under age 40
Treatments : Prolonged corticosteroid therapy > 3 months or > 1 g (cumulative dose)
Factorial
Bone densitometry scan
RadiationEach 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.
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Treatment groupsSee each treatment group below.
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
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
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
Bone mineral density of the femoral neck: Forearm
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Percentage body fat: left hip
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Body fat: left hip
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Percentage body fat: right hip
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Body fat: right hip
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Weight of participants
The weight of each participant will be recorded in kg
Height of participants
The height of each participant will be recorded in cm
Body Mass Index of participants
The body mass index (BMI) of each participant will be calculated as follows : BMI = weight \[kg\] / height 2 \[m2\]
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Centre Hospitalier Universitaire de Nīmes
Lead sponsor
University Hospital, Montpellier
Collaborator
Hôpital Edouard Herriot
Collaborator
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