[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"low-bone-mass\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:low-bone-mass":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100655073","phase-2-study-of-tst002-injection-in-postmenopausal-women-with-osteoporosis-or-low-bone-mass-100655073",false,"NCT07806331","Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass","A Randomized, Double-Blind, Parallel-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TST002 Injection in Postmenopausal Osteoporosis Patients and Middle-Aged to Older Women With Low Bone Mass","Inclusion Criteria:\n\n1. Voluntary signed informed consent; able to walk freely; willing\u002Fable to complete all study procedures.\n2. BMI 18.0-30.0 kg\u002Fm² (inclusive); body weight ≥45 kg.\n3. Postmenopausal women aged 45-80 years (inclusive) at screening, postmenopausal ≥2 years (≥12 consecutive months without spontaneous vaginal bleeding\u002Fspotting).\n4. BMD T-score \\\u003C-2.00 at lumbar spine (L1-L4 total), total hip, or femoral neck at screening; OR history of fragility fracture with T-score \\\u003C-1.00 at one of these sites (central imaging read).\n5. At least 2 contiguous evaluable vertebrae (L1-L4) and at least one evaluable hip for DXA assessment.\n6. No disease, per investigator history\u002Fexam\u002Fworkup, likely to significantly affect the study or increase health risk (documented exceptions permitted with justification).\n\nExclusion Criteria:\n\n1. BMD T-score ≤-3.50 at lumbar spine, total hip, or femoral neck at screening.\n2. Prior hip fracture.\n3. ≥2 vertebral fractures on screening lateral spine X-ray (investigator-assessed).\n4. Known skeletal, endocrine, or rheumatic disease that could confound results (e.g., Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfecta, sclerosteosis, rheumatoid arthritis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, uncontrolled thyroid disease, hyper-\u002Fhypoparathyroidism, or CN VIII compression hearing loss).\n5. Prior osteoporosis therapy (incl. trial participation) within protocol-specified washout windows (IV bisphosphonates, oral bisphosphonates, denosumab\u002Fcathepsin K inhibitors, tibolone\u002Fcinacalcet\u002Fcalcitonin, teriparatide\u002FPTH analogs, systemic estrogen\u002FSERMs, strontium ranelate\u002Ffluoride, hormonal castration therapy, systemic glucocorticoids ≥5 mg\u002Fday prednisone-equivalent for \\>14 days) - see protocol for exact windows per agent.\n6. History of TMJ disorder, TMJ osteonecrosis, or atypical fracture.\n7. Hypercalcemia or hypocalcemia (albumin-corrected) at screening.\n8. Serum 25(OH)D \\\u003C20 ng\u002FmL at screening.\n9. History of MI, or serious cardiac disease (CAD, NYHA class II-IV heart failure) within 6 months before screening.\n10. History of stroke (cerebral infarction, ischemic or hemorrhagic).\n11. ALT\u002FAST \\>3× ULN; ALP \\>2.5× ULN; total bilirubin or creatinine \\>1.5× ULN at screening.\n12. Multiple myeloma, primary\u002Fmetastatic bone malignancy, or history of skeletal radiotherapy.\n13. Malignancy within 5 years before screening (except cured skin squamous\u002Fbasal cell carcinoma or documented cured in situ cervical cancer, no recurrence ≥3 months before dosing).\n14. Known hypersensitivity to study drug.\n15. History of solid organ or bone marrow transplant.\n16. Positive HIV, syphilis, HCV antibody, or HBsAg at screening; or HBcAb-positive with detectable HBV DNA.\n17. Active tuberculosis within 6 months before screening.\n18. Participation in another clinical trial within 30 days or 5 half-lives of the investigational product (whichever longer) before screening.\n19. Any other condition the investigator judges unsuitable for participation, a safety risk, or interfering with study assessments\u002Fcompletion.","FEMALE","45 Years","80 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a randomized, double-blind, placebo- and active-controlled Phase II study evaluating the efficacy and safety of TST002 injection (a humanized monoclonal antibody) in postmenopausal women with osteoporosis or low bone mass, aged 45-80 years.\n\nApproximately 110 participants will be randomized 1:1:1:1:1 (stratified by baseline BMD T-score) to one of five arms: TST002 400 mg every 8 weeks (Q8W), TST002 800 mg Q8W, TST002 1200 mg every 12 weeks (Q12W), placebo, or open-label denosumab 60 mg subcutaneously every 24 weeks. The study includes a screening period (Day -28 to Day -1), a main study period (Week 0-24), and an extension period (Week 25-52), with all participants followed through Week 52 (Day 365).\n\nThe primary objective is to evaluate the effect of repeated IV TST002 infusions on lumbar spine bone mineral density (BMD). Secondary objectives include characterization of pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability.",[27,28],"Postmenopausal Osteoporosis","Low Bone Mass",[30,31,32,33,34,35,36],"TST002","bone mineral density","postmenopausal osteoporosis","low bone mass","sclerostin","monoclonal antibody","DXA","NOT_YET_RECRUITING","2026-09-08",{"date":40,"type":41},"2026-09-11","ACTUAL",{"date":43,"type":21},"2026-10-31",{"date":45,"type":21},"2028-10-31",{"name":47,"class":48},"Transcenta Therapeutics (Hangzhou) Co., Ltd.","INDUSTRY"]