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NCT Number: NCT06983587

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

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.

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Key information

Conditions

Age range

20 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Montpellier, Hérault, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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
  • Endocrinopathy: dysthyroidism, hypogonadism, hypercorticism, untreated acromegaly.
  • Anorexia nervosa
  • Hyperparathyroidism (even if controlled)
  • History of digestive surgery (bariatric, gastrectomy, digestive resection other than appendectomy, etc.)
  • History of organ transplant
  • Chronic infectious disease (HIV, etc.)
  • Weight loss of more than 10 kg in the last 6 months
  • Paresis, marked lameness or unloading of a limb or prolonged immobilisation of more than one month in the last 12 months

All patients on any treatment that may affect bone mass or body composition:

  • Biphosphonates (Alendronate (Fosamax® and generics), Risedronate (Actonel® and generics), Zoledronate (Aclasta® and generics)
  • Teriparatide (Forsteo®)
  • Denosumab (Prolia®)
  • Selective oestrogen receptor modulator (Clomifen, Tamoxifen, Toremifen, Raloxifen)
  • Anabolic steroids.
  • Strontium ranelate
  • Carbamazepine
  • Phenobarbital
  • Immunosuppressants
  • Antiepileptics

All patients with one of the following anomalies in the measurement area:

  • Major deformities of the wrist, hip or vertebrae
  • Compression of the vertebral bodies, cementoplasty
  • Prosthesis, implant (breast, buttock, etc.), foreign body
  • Hip paraosteoarthropathy
  • Injection of radiological contrast product, barium enema, nuclear medicine examination within 10 days

Miscellaneous :

  • Intensive sport (more than 10 h/week).
  • Extreme BMI (BMI < 18, BMI > 35 kg/m²).
  • Loss of autonomy
  • Pregnant, parturient or breast-feeding woman
  • Participation in an interventional study involving a drug or medical device or a category 1 RIPH in the 3 months prior to inclusion.

Treatment and study plan

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.

Other names: Dual-energy X-ray absorptiometry (DEXA or DXA)

Primary outcomes

  1. Bone mineral density of the femoral neck: Left side

    Time frame: Day 0, day of inclusion

    Bone mineral density (BMD in g/cm2) for the construction of Z score and T score

  2. Bone mineral density of the femoral neck: Right side

    Time frame: Day 0, day of inclusion

    Bone mineral density (BMD in g/cm2) for the construction of Z score and T score

  3. Bone mineral density of the femoral neck: Lumbar spine (L1 - L4)

    Time frame: Day 0, day of inclusion

    Bone mineral density (BMD in g/cm2) for the construction of Z score and T score

  4. Bone mineral density of the femoral neck: Forearm

    Time frame: Day 0, day of inclusion

    Bone mineral density (BMD in g/cm2) for the construction of Z score and T score

  5. Bone mineral density of the femoral neck: Whole body

    Time frame: Day 0, day of inclusion

    Bone mineral density (BMD in g/cm2) for the construction of Z score and T score

Secondary outcomes

  1. Percentage body fat: left hip

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in %

  2. Body fat: left hip

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in kg

  3. Percentage body fat: right hip

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in %

  4. Body fat: right hip

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in kg

  5. Muscle mass: left hip

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in kg

  6. Muscle mass: right hip

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in kg

  7. Percentage body fat in the region of the lumbar spine (L1 - L4)

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in %

  8. Body fat in the region of the lumbar spine (L1 - L4)

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in kg

  9. Muscle mass in the region of the lumbar spine (L1 - L4)

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in kg

  10. Percentage body fat: forearm

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in %

  11. Body fat: forearm

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in kg

  12. Muscle mass: forearm

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in kg

  13. Percentage body fat: whole body

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in %

  14. Body fat: whole body

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in kg

  15. Muscle mass: whole body

    Time frame: Day 0, day of inclusion

    Measured automatically by the STRATOS DR X-ray bone densitometer in kg

Other outcomes

  1. Weight of participants

    Time frame: Day 0, day of inclusion

    The weight of each participant will be recorded in kg

  2. Height of participants

    Time frame: Day 0, day of inclusion

    The height of each participant will be recorded in cm

  3. Body Mass Index of participants

    Time frame: Day 0, day of inclusion

    The body mass index (BMI) of each participant will be calculated as follows : BMI = weight [kg] / height 2 [m2]

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

0466684236

Vincent BOUDOUSQ, Dr.

CONTACT

[email protected]

+334 66 68 32 66

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Hôpital Edouard Herriot
  • University Hospital, Montpellier

Registry information

Official study title

Study to Establish Reference Curves for Bone Mineral Density (BMD) and Body Composition (BC) in Women Aged 20-89 MONIKA

Acronym: MONIKA

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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