Reference Curves for Bone Mineral Density and Body Composition in Women Aged 20-89

NCT06983587 | Not Yet Recruiting

• 1 other identifier: IDIL/2023/VB-01
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bone Density

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  Day 0, day of inclusion

Secondary Outcomes (15)

• Percentage body fat: left hip

  Day 0, day of inclusion

• Body fat: left hip

  Day 0, day of inclusion

• Percentage body fat: right hip

  Day 0, day of inclusion

• Body fat: right hip

  Day 0, day of inclusion

• Muscle mass: left hip

  Day 0, day of inclusion

Other Outcomes (3)

• Weight of participants

  Day 0, day of inclusion

• Height of participants

  Day 0, day of inclusion

• Body Mass Index of participants

  Day 0, day of inclusion

Study Arms (7)

Women aged 20-29

OTHER

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

Women aged 30-39

OTHER

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

Women aged 40-49

OTHER

Group including 50 subjects.

Radiation: Bone densitometry scan

Women aged 50-59

OTHER

Group including 50 subjects.

Radiation: Bone densitometry scan

Women aged 60-69

OTHER

Group including 50 subjects.

Radiation: Bone densitometry scan

Women aged 70-79

OTHER

Group including 50 subjects.

Radiation: Bone densitometry scan

Women aged 80-89

OTHER

Only 25 subjects will be included in this age group for reasons of feasibility.

Radiation: Bone densitometry scan

Interventions

Bone densitometry scan RADIATION

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)

Women aged 20-29; Women aged 30-39; Women aged 40-49; Women aged 50-59; Women aged 60-69; Women aged 70-79; Women aged 80-89

Eligibility Criteria

• Age: 20 Years - 89 Years
• Gender Eligibility Details: People with vaginas. Healthy female volunteers.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients presenting one of the following major risk factors:
• 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)
• Immobilization of more than 3 months, less than 12 months old
• Patients presenting one of the following pathologies affecting bone, muscle or adipose tissue:
• Chronic inflammatory bowel disease (IBD) (Crohn's disease, ulcerative colitis) and untreated celiac disease
• Renal insufficiency on dialysis or patients with nephrology follow-up
• Known hypercalciuria
• Osteomalacia, rickets, osteogenesis imperfecta
• Osteopathy (Paget's disease, osteopetrosis, etc.)
• Chronic inflammatory rheumatism
• Haemopathy, neoplasia
• Hepatic insufficiency or chronic hepatitis

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• University Hospital, Montpellier: collaborator
• Hôpital Edouard Herriot: collaborator

Study Sites (2)

University Hospital

Montpellier, Hérault, 34295, France

Location

Hôpital E Herriot UMR_S 1033

Lyon, 69700, France

Location

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Vincent BOUDOUSQ, Dr.

CONTACT

+334 66 68 32 66; vincent.boudousq@chu-nimes.fr

Anissa MEGZARI

CONTACT

0466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)