[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100201856":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":38,"responsibleParty":49,"collaborators":37,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":37,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":37,"enrollmentInfo":60,"targetDuration":37,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":71,"whyStopped":37,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Hanlim Pharm. Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Risenex M","EXPERIMENTAL","Patients who were treated with Resenex M (Risendronate\u002FCholecalciferol combination in one tablet) once a month for 12months",[13],"Drug: Risedronate\u002FCholecalciferol combination(montly)",{"label":15,"type":16,"description":17,"interventionNames":18},"Risenex Plus","ACTIVE_COMPARATOR","Patients who were treated with Risenex plus (Risendronate\u002FCholecalciferol combination in one tablet) once a week for 12months",[13,19],"Drug: Risedronate\u002FCholecalciferol combination(weekly)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Risedronate\u002FCholecalciferol combination(montly)","once a month",[9,15],[9],{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Risedronate\u002FCholecalciferol combination(weekly)","once a week",[15],[15],[33],{"name":34,"affiliation":35,"role":36},"Youngki Min, MD","Samsung Medical Center Seoul","PRINCIPAL_INVESTIGATOR",null,[39],{"facility":40,"status":37,"city":41,"state":37,"zip":37,"country":42,"countryCode":37,"cosmosGeoPoint":43,"geoPoint":48,"contacts":37},"Samsung Medical Center","Seoul","South Korea",{"type":44,"coordinates":45},"Point",[46,47],126.9784,37.566,{"lat":47,"lon":46},{"type":50,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100201856","phase-4-to-evaluate-the-efficacy-and-the-safety-of-monthly-versus-weekly-oral-risedronate-with-vitamin-d-in-compliance-improvement-of-vitamin-d-and-bmd-in-korean-postmenopausal-osteoporotic-women-100201856",false,"NCT01904110","To Evaluate the Efficacy and the Safety of Monthly Versus Weekly Oral Risedronate With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women","For 12months, the Multi Center, Randomized, Open-label Comparative Clinical Study to Evaluate the Efficacy and the Safety of Monthly(RisenexM Group) Versus Weekly Oral Risedronate(Risenexsplus Group) With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women(Phase IV)","Inclusion Criteria:\n\n1. Female osteoporosis patients over 19years of age(with menopause).\n\n   Definition of osteporosis\n   * They had a BMD T-score -2.5 or less at mean Lumbar spine(L1\\~L4), Femoral neck or total. Or evidence of at least one vertebral fracture.\n\n   Definition of menopause(can be one of three condition)\n   * For 12months spontaneous amenorrhea\n   * For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40 mlIU\u002FmL and over\n   * 6weeks after bilateral ovariectomy whether hysterectomy of not\n2. Patients who can be treated with oral bisphosphonate drugs\n3. Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry)\n4. Patients who made a voluntary agreement after explanation of this study\n5. Patients who participated in clinical trial(HL\\_RSNP\\_401) must have taken the Risenexplus and finish the study for 12 months.\n\nExclusion Criteria:\n\n1. Patients with esophagus disorder.\n2. Patients administered with osteoprosis therapy(except calcium,Vit.D medication) within previous 3 months\n3. Patients with serum calcium concentrations 8.0mg\u002FdL under.\n4. Patients with severe nephropathy(serum creatinine\\> doulble of normal level\n5. Patients with unable to sit upright or stand 30minutes.","FEMALE","19 Years",{"count":61,"type":62},196,"ACTUAL","INTERVENTIONAL",[65],"PHASE4","The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal osteoporotic women(Phase IV)",[68],"Osteoporosis",[70],"Risedronate,cholecalciferol,BMD,montly,weekly,compliance","COMPLETED","2018-08-28",{"date":74,"type":62},"2018-08-29",{"date":76,"type":37},"2012-12",{"date":78,"type":62},"2016-03-31",{"name":5,"class":6},1]