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

ConditionBone Density
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-89
SponsorCentre Hospitalier Universitaire de Nīmes

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

425 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Centre Hospitalier Universitaire de Nīmes

Lead sponsor

University Hospital, Montpellier

Collaborator

Hôpital Edouard Herriot

Collaborator