[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591681":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":42,"centralContacts":43,"locations":53,"responsibleParty":89,"collaborators":91,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":42,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":42,"overallStatus":117,"whyStopped":42,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Nīmes","OTHER",[8,13,17,21,24,27,30],{"label":9,"type":6,"description":10,"interventionNames":11},"Women aged 20-29","This group will be used to construct the T-score equation, and thus define the thresholds for osteopenia and osteoporosis. To ensure adequate precision for this T-score, 175 subjects will be included in this age group. With this number of subjects, the following accuracies for two of the sites of interest (hip and L1-L4) are expected:\n\nFor the hip, the expected bone mineral density value is 0.95 (SD=0.11) according to local data consistent with Arlot et al. Inclusion of 175 subjects would give a ½ width 95% confidence interval (IC95%) of the mean would be around 0.016, and the half width standard deviation of 0.012 For L1-L4, the expected bone mineral density value is 0.99 (SD=0.11) according to local data consistent with Arlot et al. The ½ width of the 95% confidence interval (IC95%) of the mean would be around 0.016, and the half-width standard deviation of 0.012.",[12],"Radiation: Bone densitometry scan",{"label":14,"type":6,"description":15,"interventionNames":16},"Women aged 30-39","For the 30-39 age group, only 25 subjects will be included, given the constancy of bone mineral density in this age group compared with the 20-29 age group. In addition, the results of the analyses will take the form of a Z-score equation, estimated using a regression method (i.e. overall and not a z-score per age group). As there will be many subjects under 30 and over 40, this will ensure (by interpolation) an equivalent precision in these age brackets to that of the adjacent age categories.",[12],{"label":18,"type":6,"description":19,"interventionNames":20},"Women aged 40-49","Group including 50 subjects.",[12],{"label":22,"type":6,"description":19,"interventionNames":23},"Women aged 50-59",[12],{"label":25,"type":6,"description":19,"interventionNames":26},"Women aged 60-69",[12],{"label":28,"type":6,"description":19,"interventionNames":29},"Women aged 70-79",[12],{"label":31,"type":6,"description":32,"interventionNames":33},"Women aged 80-89","Only 25 subjects will be included in this age group for reasons of feasibility.",[12],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"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).\n\nIn general, the time for a scan is less than 1 min for the spine, less than than 1 min for the femur, less than 1 min for the forearm and around 4 min for the whole body.\n\nThe total duration of the patient's participation in this research will be approximately 2 hours.",[9,14,18,22,25,28,31],[41],"Dual-energy X-ray absorptiometry (DEXA or DXA)",null,[44,49],{"name":45,"role":46,"phone":47,"phoneExt":42,"email":48},"Vincent BOUDOUSQ, Dr.","CONTACT","+334 66 68 32 66","vincent.boudousq@chu-nimes.fr",{"name":50,"role":46,"phone":51,"phoneExt":42,"email":52},"Anissa MEGZARI","0466684236","drc@chu-nimes.fr",[54,75],{"facility":55,"status":42,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"University Hospital","Montpellier","Hérault","34295","France","FR",{"type":62,"coordinates":63},"Point",[64,65],3.87635,43.61093,{"lat":65,"lon":64},[68,72],{"name":69,"role":46,"phone":70,"phoneExt":42,"email":71},"Denis Mariano Goulart, Prof.","+334 64 33 85 98","d-mariano_goulart@chu-montpellier.fr",{"name":73,"role":74,"phone":42,"phoneExt":42,"email":42},"Laurent Maïmoun","SUB_INVESTIGATOR",{"facility":76,"status":42,"city":77,"state":42,"zip":78,"country":59,"countryCode":60,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Hôpital E Herriot UMR_S 1033","Lyon","69700",{"type":62,"coordinates":80},[81,82],4.84789,45.74906,{"lat":82,"lon":81},[85],{"name":86,"role":46,"phone":87,"phoneExt":42,"email":88},"Roland CHAPURLAT, Pr.","+33472117482","roland.chapurlat@inserm.fr",{"type":90,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[92,94],{"name":93,"class":6},"University Hospital, Montpellier",{"name":95,"class":6},"Hôpital Edouard Herriot","100591681","reference-curves-for-bone-mineral-density-and-body-composition-in-women-aged-20-89-100591681",false,"NCT06983587","Reference Curves for Bone Mineral Density and Body Composition in Women Aged 20-89","Study to Establish Reference Curves for Bone Mineral Density (BMD) and Body Composition (BC) in Women Aged 20-89 MONIKA","MONIKA","Inclusion Criteria:\n\n* 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\n* Person affiliated to or benefiting from a social security scheme\n* Free, informed consent signed by the participant and the investigator (on the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Patients presenting one of the following major risk factors:\n* Fragility fracture defined as a spontaneous or low-kinetic fracture (≤ one fall from height)\n* Hip fracture in a first-degree relative\n* Early menopause (\\\u003C age 40), Hysterectomy (complete \\\u003C 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\n* Treatments : Prolonged corticosteroid therapy \\> 3 months or \\> 1 g (cumulative dose)\n* Immobilization of more than 3 months, less than 12 months old\n* Patients presenting one of the following pathologies affecting bone, muscle or adipose tissue:\n* Chronic inflammatory bowel disease (IBD) (Crohn's disease, ulcerative colitis) and untreated celiac disease\n* Renal insufficiency on dialysis or patients with nephrology follow-up\n* Known hypercalciuria\n* Osteomalacia, rickets, osteogenesis imperfecta\n* Osteopathy (Paget's disease, osteopetrosis, etc.)\n* Chronic inflammatory rheumatism\n* Haemopathy, neoplasia\n* Hepatic insufficiency or chronic hepatitis\n* Endocrinopathy: dysthyroidism, hypogonadism, hypercorticism, untreated acromegaly.\n* Anorexia nervosa\n* Hyperparathyroidism (even if controlled)\n* History of digestive surgery (bariatric, gastrectomy, digestive resection other than appendectomy, etc.)\n* History of organ transplant\n* Chronic infectious disease (HIV, etc.)\n* Weight loss of more than 10 kg in the last 6 months\n* Paresis, marked lameness or unloading of a limb or prolonged immobilisation of more than one month in the last 12 months\n\nAll patients on any treatment that may affect bone mass or body composition:\n\n* Biphosphonates (Alendronate (Fosamax® and generics), Risedronate (Actonel® and generics), Zoledronate (Aclasta® and generics)\n* Teriparatide (Forsteo®)\n* Denosumab (Prolia®)\n* Selective oestrogen receptor modulator (Clomifen, Tamoxifen, Toremifen, Raloxifen)\n* Anabolic steroids.\n* Strontium ranelate\n* Carbamazepine\n* Phenobarbital\n* Immunosuppressants\n* Antiepileptics\n\nAll patients with one of the following anomalies in the measurement area:\n\n* Major deformities of the wrist, hip or vertebrae\n* Compression of the vertebral bodies, cementoplasty\n* Prosthesis, implant (breast, buttock, etc.), foreign body\n* Hip paraosteoarthropathy\n* Injection of radiological contrast product, barium enema, nuclear medicine examination within 10 days\n\nMiscellaneous :\n\n* Intensive sport (more than 10 h\u002Fweek).\n* Extreme BMI (BMI \\\u003C 18, BMI \\> 35 kg\u002Fm²).\n* Loss of autonomy\n* Pregnant, parturient or breast-feeding woman\n* Participation in an interventional study involving a drug or medical device or a category 1 RIPH in the 3 months prior to inclusion.",true,"FEMALE","20 Years","89 Years",{"count":109,"type":110},425,"ESTIMATED","INTERVENTIONAL",[113],"NA","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.\n\nSome 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.\n\nThis 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.",[116],"Bone Density","NOT_YET_RECRUITING","2025-05-14",{"date":120,"type":121},"2025-05-21","ACTUAL",{"date":123,"type":110},"2025-06-01",{"date":125,"type":110},"2029-09",{"name":5,"class":6},2]