[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585107":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":11,"responsibleParty":33,"collaborators":11,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":11,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":11,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":11,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"QLG2128","EXPERIMENTAL",null,[13],"Drug: QLG2128",{"label":15,"type":16,"description":11,"interventionNames":17},"Teriparatide Injection","ACTIVE_COMPARATOR",[18],"Drug: Teriparatide Injection",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Recommended dosage is 80 μg subcutaneously once daily，52week",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Recommended dosage is 20μg subcutaneously once daily，52week",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"zhenlin Zhang, Doctor","CONTACT","13621673716","zzl2002@medmail.com",{"type":34,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100585107","phase-3-to-evaluate-the-efficacy-and-safety-of-abaloparatide-injection-qlg2128-in-the-treatment-of-postmenopausal-women-with-osteoporosis-and-at-high-risk-of-fracture-100585107",false,"NCT06898060","To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture","A Multicenter, Randomized, Open-label, Parallel Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture","Inclusion Criteria:\n\n* Postmenopausal women who can walk freely (≥50 and ≤85 years);\n* The patient has a body mass index(BMI) of 17.0 kg\u002Fm2 to 30 kg\u002Fm2；\n* The patient has a bone mineral density T-score≤-2.5 and \\> -5.0 at the lumbar spine (L1-L4) or femoral neck or total hip by dual energy x-ray absorptiometry (DXA)；\n* The patient has at least one of the following high risk factors of fracture: 1) history of previous fragility fractures; 2) family history of hip fragility fracture; 3) age≥70 years; 4) BMI≤19.0 kg\u002Fm2；5) Currently smoking.\n* The patient with at least 2 consecutive vertebrae(L1 to L4) and at least 1 hip can be evaluated for BMD.\n\nExclusion Criteria:\n\n* In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism；\n* History of osteosarcoma；\n* History of orthostatic hypotension；\n* Currently suffering from active urinary calculus；\n* Received anti-osteoporosis treatment that does not meet protocol requirements；\n* Received medication that affects bone metabolism within 4 weeks prior to screening, or is planned to use prohibited drugs\u002Fnon-drug therapy under the protocol during the study period.","ALL","50 Years","85 Years",{"count":46,"type":47},282,"ESTIMATED","INTERVENTIONAL",[50],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.",[53],"Postmenopausal Women With Osteoporosis","NOT_YET_RECRUITING","2025-03-20",{"date":57,"type":58},"2025-03-27","ACTUAL",{"date":60,"type":47},"2025-06",{"date":62,"type":47},"2027-05",{"name":5,"class":6}]