[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postmenopausal-women-with-osteoporosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postmenopausal-women-with-osteoporosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100638487","phase-2-a-phase-ii-clinical-trial-of-the-safety-and-efficacy-of-sal056-at-different-doses-and-dosing-regimens-100638487",false,"NCT07579936","A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens","Evaluation of the Safety and Efficacy of SAL056 (Recombinant Human Parathyroid Hormone [1-34] for Injection [56.5 μg]) at Different Doses and Dosing Regimens: A Multicenter, Randomized, Open-Label, Parallel-Controlled Phase II Clinical Trial","Inclusion Criteria:\n\n1.Female, with independent mobility, 45 years ≤ age ≤ 80 years; 2.Natural menopause for ≥3 years, or surgical menopause for ≥3 years (surgery must be performed after age 40); for women with surgical menopause, follicle-stimulating hormone \\>40 mIU\u002FmL is required; 3.18 ≤ body mass index ≤ 30 kg\u002Fm²; 4.Previous definitive diagnosis of osteoporosis; 5.Patients who are able to independently go to the hospital to receive injections of the investigational drug; 6. Voluntarily participate in this trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Received teriparatide treatment within 1 month prior to screening;\n2. Patients with secondary osteoporosis, such as Cushing's syndrome, hyperprolactinemia, malabsorption syndrome or various gastrointestinal diseases related to malabsorption (such as Crohn's disease, chronic pancreatitis, etc.), rheumatoid arthritis, gout, multiple myeloma, etc.;\n3. Patients with other diseases affecting calcium or bone metabolism, including hyperparathyroidism or hypoparathyroidism, hyperthyroidism or hypothyroidism (patients with hyperthyroidism or hypothyroidism receiving stable treatment with normal hormone levels are eligible; or patients with hypothyroidism where 5.5 mIU\u002FL \\\u003C thyroid-stimulating hormone ≤ 10.0 mIU\u002FL but free thyroxine is within normal range are eligible), osteogenesis imperfecta, osteomalacia, Paget's disease of bone, hypercalcemia, hypocalcemia, active urolithiasis, etc.;\n4. Patients who require treatment with other anti-osteoporosis drugs during the trial or long-term\u002Fcontinuous use of digitalis glycosides such as digoxin;\n5. Patients with severe renal disease (serum creatinine \\>1.5 times the upper limit of normal), uncontrolled hypertension \\[systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg\\], severe heart disease (such as myocardial infarction, unstable angina pectoris, heart failure with NYHA functional class III-IV, severe arrhythmias, etc.), cerebral infarction (excluding lacunar cerebral infarction) or occlusive arteriosclerosis, malignant tumors, and those with other serious underlying diseases;\n6. Patients with esophageal abnormalities that cause delayed esophageal emptying (such as reflux esophagitis, esophageal stricture or achalasia) or those with difficulty swallowing;\n7. Abnormal laboratory findings detected during the screening period, including any of the following abnormal indicators:\n\n1\\) Alkaline phosphatase \\>1.3 times the upper limit of normal; 2) Alanine aminotransferase or aspartate aminotransferase \\>3.0 times the upper limit of normal; 3)Total bilirubin \\>1.5 times the upper limit of normal; 4) Glycated hemoglobin ≥8.5%; 5)White blood cell count \\\u003C3.0×10⁹\u002FL, or hemoglobin \\\u003C100g\u002FL, or platelet count \\\u003C90×10⁹\u002FL; 6)Parathyroid hormone \\>1.5 times the upper limit of normal; 8. Positive for hepatitis C virus antibody, or Treponema pallidum antibody, or human immunodeficiency virus antibody; or positive for hepatitis B surface antigen (HBsAg) with peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer ≥1×103 copies\u002FmL (if HBsAg is positive and peripheral blood HBV DNA titer \\\u003C1×103 copies\u002FmL, the trial participant is eligible if the investigator considers the participant's chronic hepatitis B to be in a stable phase and will not increase the risk to the trial participant); 9. History of major surgery (excluding fracture surgery) within 6 months prior to signing the informed consent form, or planned major surgery during the study period; 10. Known history of organ transplantation; 11. History of drug abuse within 6 months prior to informed consent; 12. Individuals with known allergy to the investigational drug; 13. Patients who have previously received radiation therapy to the skeletal system; 14. Individuals with mental illness or cognitive impairment due to any cause; 15. Patients deemed unsuitable to participate in this study by researchers based on risk-benefit considerations.","FEMALE","45 Years","80 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, randomized, open-label, parallel-controlled Phase II study designed to evaluate the differences in safety among four different dosing regimens of SAL056.",[27],"Postmenopausal Women With Osteoporosis",[27,29,30],"high risk of fracture","Teriparatide","RECRUITING","2026-05-05",{"date":34,"type":35},"2026-05-12","ACTUAL",{"date":37,"type":35},"2026-04-30",{"date":39,"type":21},"2026-11-30",{"name":41,"class":42},"Shenzhen Salubris Pharmaceuticals Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"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","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":55,"type":21},282,[57],"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.",[27],"NOT_YET_RECRUITING","2025-03-20",{"date":63,"type":35},"2025-03-27",{"date":65,"type":21},"2025-06",{"date":67,"type":21},"2027-05",{"name":69,"class":42},"Qilu Pharmaceutical Co., Ltd."]