Status:
NOT_YET_RECRUITING
Reference Curves for Bone Mineral Density and Body Composition in Women Aged 20-89
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborating Sponsors:
University Hospital, Montpellier
Hôpital Edouard Herriot
Conditions:
Bone Density
Eligibility:
FEMALE
20-89 years
Phase:
NA
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...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT06983587
Start Date
June 1 2025
End Date
September 1 2029
Last Update
May 21 2025
Active Locations (2)
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1
University Hospital
Montpellier, Hérault, France, 34295
2
Hôpital E Herriot UMR_S 1033
Lyon, France, 69700