Reference Curves for Bone Mineral Density and Body Composition in Women Aged 20-89
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Bone mineral density of the femoral neck: Left side — Day 0, day of inclusion
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 — Day 0, day of inclusion
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) — Day 0, day of inclusion
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score - Bone mineral density of the femoral neck: Forearm — Day 0, day of inclusion
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score - Bone mineral density of the femoral neck: Whole body — Day 0, day of inclusion
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital | Montpellier | Hérault | |
| Hôpital E Herriot UMR_S 1033 | Lyon | France |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06983587 on ClinicalTrials.gov ↗ ← All trials in France