[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568591":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":74,"centralContacts":78,"locations":88,"responsibleParty":121,"collaborators":10,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":10,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":91,"whyStopped":10,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Nīmes","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Sub-group of 280 patients derived from the MONIKA study",null,[12,13,14,15,16,17,18,19,20,21,22,23],"Diagnostic Test: Blood sample","Diagnostic Test: Saliva sample","Diagnostic Test: Grip test","Other: MicroFET2® maximum isometric force test","Other: Maximum isometric knee extension bench test.","Other: The SPPB (Short Physical Performance Battery)","Other: The 6-minute walking test.","Other: Segmental impedancemetry examination.","Other: Indirect calorimetry test.","Other: Fardellone's questionnaire","Other: ONAPS questionnaire","Other: Dietary intake.questionnaire",[25,30,34,38,42,46,50,54,58,62,66,70],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DIAGNOSTIC_TEST","Blood sample","36 ml of blood in 3 x 7 ml dry tubes, 1 x 5 ml EDTA tube, 1 x 5 ml heparinized tube, 1 x 5 ml anti-protease tube)",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Saliva sample","5 ml of saliva will be taken.",[9],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Grip test","The grip strength of the dominant arm will be measured with the participant in a standing position, with the arm close to the body and the elbow at 90◦ flexion, while the non-dominant arm will be positioned alongside the body. Three measurements will be taken for the dominant hand, and the mean value will be calculated and used for analysis. One minute is allowed between each repetition, to avoid muscle fatigue. Dynamometer quality control is ensured by regularly checking known resistance values.",[9],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"MicroFET2® maximum isometric force test","The microFET2 device is used to test isometric force. The microFET2 dynamometer is battery-powered and ergonomically designed to fit in the palm of the hand. The system is microprocessor-controlled to provide accurate, repeatable muscle force readings. The microFET Clinical software automatically performs calculations and validity tests, and allows graphs to be generated from the data, enabling reports of different patient tests to be compared",[9],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"Maximum isometric knee extension bench test.","The maximal isometric knee extension strength test on a specially-adapted strength bench consists in performing 3 maximal contractions with 1 minute's rest between each test.",[9],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":10},"The SPPB (Short Physical Performance Battery)","Battery of tests comprising a balance test, a walking speed test and a chair-lift test",[9],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":10},"The 6-minute walking test.","Muscular function will be determined by the 6-minute walk test to assess aerobic endurance. Participants will be asked to walk for 6 min as fast as possible on a shuttle track. The distance (m) covered in 6 min will be measured. Walking speed (m\u002Fs) will be calculated as the distance (m) covered in 6 min. A walking speed \\\u003C0.8 m\u002Fs has been defined as a low value.",[9],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":10},"Segmental impedancemetry examination.","Segmental impedancemetry involves measuring body composition using the body's resistance to the passage of a low-intensity electric current. This test is harmless to the body.",[9],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":10},"Indirect calorimetry test.","An Indirect calorimetry is the standard method for measuring energy expenditure at rest. It is based on the principle that the human body burns nutrients using O2 and producing CO2.",[9],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":10},"Fardellone's questionnaire","Completion of a questionnaires on calcium intake (Fardellone)",[9],{"type":6,"name":67,"description":68,"armGroupLabels":69,"otherNames":10},"ONAPS questionnaire","The ONAPS questionnaire contains questions on physical activity and sedentariness",[9],{"type":6,"name":71,"description":72,"armGroupLabels":73,"otherNames":10},"Dietary intake.questionnaire","The dietary intake questionnaire contains questions regarding the person's eating habits - how many meals a day, where they eat, whether they eat alone, what foods they eat\u002Fdrink and whether they are following a particular diet and, if so, the reasons why.",[9],[75],{"name":76,"affiliation":5,"role":77},"Thibault MURA, Prof.","STUDY_DIRECTOR",[79,84],{"name":80,"role":81,"phone":82,"phoneExt":10,"email":83},"Vincent BOUDOUSQ, Dr","CONTACT","+334.66.68.32.66","vincent.boudousq@chu-nimes.fr",{"name":85,"role":81,"phone":86,"phoneExt":10,"email":87},"Anissa MEGZARI","0466684236","drc@chu-nimes.fr",[89,109],{"facility":90,"status":91,"city":92,"state":10,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"C.H.R.U. Lapeyronie","RECRUITING","Montpellier","34295","France","FR",{"type":97,"coordinates":98},"Point",[99,100],3.87635,43.61093,{"lat":100,"lon":99},[103,107],{"name":104,"role":81,"phone":105,"phoneExt":10,"email":106},"Denis Mariano Goulart, Pr","+334 64 33 85 98","d-mariano_goulart@chu-montpellier.fr",{"name":104,"role":108,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":110,"status":91,"city":111,"state":10,"zip":112,"country":94,"countryCode":95,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Chu Nimes","Nîmes","30029",{"type":97,"coordinates":114},[115,116],4.35788,43.83665,{"lat":116,"lon":115},[119,120],{"name":80,"role":81,"phone":82,"phoneExt":10,"email":83},{"name":80,"role":108,"phone":10,"phoneExt":10,"email":10},{"type":122,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100568591","mediating-role-of-myokines-in-the-dialogue-between-muscle-and-bone-tissue-in-a-population-of-healthy-women-aged-20-89-years-100568591",false,"NCT06683222","Mediating Role of Myokines in the Dialogue Between Muscle and Bone Tissue in a Population of Healthy Women Aged 20-89 Years","Analysis of the Mediating Role of Myokines in the Dialogue Between Muscle and Bone Tissue in a Population of Healthy Women Aged 20-89 Years","MyOs","Inclusion Criteria:\n\n* Self-reported Caucasian ethnicity (Europe, Middle East, North Africa) only as there is a difference in BMD by ethnicity.\n* Person affiliated with or benefiting from a social security scheme.\n* Free, informed consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Fragility fracture defined as a spontaneous or low-kinetic fracture (≤ one fall from height).\n* Early menopause (\\\u003C 40 years), hysterectomy (complete \\\u003C 40 years), primary amenorrhea (absence of menstruation before 15 years), current amenorrhea of more than 3 months without contraceptive if the patient is less than 40 years old.\n* Patients on treatments: prolonged corticosteroid therapy \\> 3 months or \\> 1 g (cumulative dose).\n* Immobilization of more than 3 months, less than 12 months old.\n* Hip fracture in a first-degree relative.\n\nPatients with any of the following pathologies affecting bone, muscle or adipose tissue:\n\n* 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* Hemopathy, neoplasia.\n* Hepatic insufficiency or chronic hepatitis.\n* Endocrinopathy: diabetes, dysthyroidism, hypogonadism, hypercorticism, untreated acromegaly.\n* Anorexia nervosa.\n* Hyperparathyroidism (even controlled).\n* History of digestive surgery (bariatric, gastrectomy, digestive resection other than appendectomy, etc.).\n* History of organ transplantation.\n* Chronic infectious disease (HIV, etc.).\n* Weight loss of more than 10 kg within 6 months.\n* Paresis, marked lameness or unloading of a limb, or prolonged immobilization of more than one month in the last 12 months.\n* Patients on treatments that may affect bone mass or body composition:\n* Biphosphonates (Alendronate (Fosamax® and generics), Risedronate (Actonel® and generics), Zoledronate (Aclasta® and generics).\n* Teriparatide (Forsteo®).\n* Denosumab (Prolia®)\n* Selective estrogen receptor modulators (Clomifene, Tamoxifene, Toremifene, Raloxifene).\n* Anabolic steroids.\n* Strontium ranelate.\n* Carbamazepine.\n* Phenobarbital.\n* Immunosuppressants.\n* Patients on anti-epileptics.\n* Patients with any of the following abnormalities in the measurement area:\n* Major deformities of the wrist, hip or vertebrae.\n* Compression of vertebral bodies, cementoplasty.\n* Prosthesis, implant (breast, buttock, etc.), foreign body.\n* Hip paraosteoarthropathy.\n* Injection of radiological contrast medium, barium enema, nuclear medicine examination within 10 days.\n* Intensive sport (more than 10 h\u002Fweek).\n* Extreme BMI (BMI \\\u003C 18, BMI \\> 35 kg\u002Fm²).\n* Loss of autonomy.\n* People with neurodegenerative disorders affecting their ability to give consent.\n* Pregnant, parturient or breast-feeding women.\n* Participation in an interventional study involving a drug or medical device or a category 1 RIPH within 3 months prior to inclusion.",true,"FEMALE","20 Years","89 Years",{"count":136,"type":137},280,"ESTIMATED","INTERVENTIONAL",[140],"NA","The main hypothesis is that muscle acts on bone tissue via the secretion of myokines (myostatin, follistatin, irisin). This is based on previous results showing that muscle mass in different patient populations with very different body mass indexes (anorexic or obese patients) is significantly and independently associated with bone mineral density.",[143],"Bone Density",[145],"Myokines","2024-11-27",{"date":148,"type":149},"2024-11-29","ACTUAL",{"date":151,"type":149},"2024-11-06",{"date":153,"type":137},"2029-09-30",{"name":5,"class":6},2]