About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Bone densitometry scan
Treatment groups
7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Centre Hospitalier Universitaire de Nīmes
Lead sponsor
University Hospital, Montpellier
Collaborator
Hôpital Edouard Herriot
Collaborator