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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · May 14, 2025

Keywords

ClinConnect Summary

The MONIKA study is a research trial that aims to create updated reference values for bone mineral density and body composition in women aged 20 to 89. This means the study will look at how strong bones are and the balance of fat and lean mass in women across different age groups. By examining 425 healthy women from Nîmes, Montpellier, and Lyon, the researchers hope to better understand how bones and body fat interact and change over time.

To participate in this study, women must be healthy and come from European, Middle Eastern, or North African backgrounds. They should not have any significant risk factors for bone issues, such as a history of fractures or certain medical conditions. Those who join can expect to undergo a bone density scan at different sites in their body, which is a painless procedure that will help gather important data. It's also worth noting that the study is not yet recruiting participants, so if you or someone you know is interested, there will be more information available in the future.

Gender

FEMALE

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.