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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• 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

Primary outcome measures

• Bone mineral density of the femoral neck: Left side [Time frame: Day 0, day of inclusion]
• Bone mineral density of the femoral neck: Right side [Time frame: Day 0, day of inclusion]
• Bone mineral density of the femoral neck: Lumbar spine (L1 - L4) [Time frame: Day 0, day of inclusion]
• Bone mineral density of the femoral neck: Forearm [Time frame: Day 0, day of inclusion]
• Bone mineral density of the femoral neck: Whole body [Time frame: Day 0, day of inclusion]

Secondary outcome measures (12)

• Percentage body fat: left hip [Time frame: Day 0, day of inclusion]
• Body fat: left hip [Time frame: Day 0, day of inclusion]
• Percentage body fat: right hip [Time frame: Day 0, day of inclusion]
• Body fat: right hip [Time frame: Day 0, day of inclusion]
• Muscle mass: left hip [Time frame: Day 0, day of inclusion]
• Muscle mass: right hip [Time frame: Day 0, day of inclusion]
• Percentage body fat in the region of the lumbar spine (L1 - L4) [Time frame: Day 0, day of inclusion]
• Body fat in the region of the lumbar spine (L1 - L4) [Time frame: Day 0, day of inclusion]
• Muscle mass in the region of the lumbar spine (L1 - L4) [Time frame: Day 0, day of inclusion]
• Percentage body fat: forearm [Time frame: Day 0, day of inclusion]
• Body fat: forearm [Time frame: Day 0, day of inclusion]
• Muscle mass: forearm [Time frame: Day 0, day of inclusion]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Factorial

Masking

Open label

Primary purpose

Health services research

Study locations

France · 2 centers

• University Hospital — Montpellier
• Hôpital E Herriot UMR_S 1033 — Lyon

Identifiers

NCT: NCT06983587 · IDIL/2023/VB-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗