[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-osteoporosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-osteoporosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100624211","phase-4-the-comparison-of-ibandronate-and-zoledronic-acid-after-denosumab-discontinuation-100624211",false,"NCT07406685","The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation","The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation: A Randomized Non-inferiority Trial","Inclusion Criteria:\n\n1. Postmenopausal women aged 50 to 85 years.\n2. BMD T-score ≤ -1.5 and \\> -3.0 at the lumbar spine or total hip.\n3. Regular treatment with denosumab administered every 6 months for at least 1 year and less than 3 years (3 to 5 doses).\n4. Physically and mentally capable of understanding and complying with the study protocol and follow-up.\n5. Signed informed consent.\n\nExclusion Criteria:\n\n1. History of fragility or osteoporotic fracture within the past 12 months.\n2. Current or prior treatment within the past 12 months with osteoporosis medications other than denosumab, including Romosozumab, Teriparatide, Alendronate, Ibandronate, Zoledronic acid, Risedronate and Raloxifene.\n3. Allergy to bisphosphonates.\n4. Secondary osteoporosis.\n5. Metabolic bone diseases.\n6. Any autoimmune disease.\n7. Requirement for long-term use of medications known to affect bone metabolism (e.g., systemic glucocorticoids or hormone therapy).\n8. Primary or metastatic bone tumors.\n9. Cancer patients, except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years.\n10. Hypocalcemia.\n11. Vitamin D deficiency (serum 25-hydroxyvitamin D \\\u003C 25 ng\u002FmL).\n12. Renal disease (eGFR \\\u003C 35 mL\u002Fmin\u002F1.73 m²) or dialysis patients.\n13. Planned dental procedures (e.g., extractions, implants) within the next year.\n14. Smoking more than one pack per day (except for those who have quit for over ten years).","FEMALE","50 Years","85 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study is a prospective, multicenter, open-label, randomized non-inferiority trial comparing intravenous ibandronate and zoledronic acid as sequential therapy after denosumab discontinuation in postmenopausal women with osteoporosis. This trial primarily targets patients with short-term denosumab exposure (less than three years) and is conducted as a preliminary investigation. The findings are expected to provide foundational evidence to inform the design of future studies assessing sequential therapies following longer-term denosumab treatment.",[27,28,29,30],"Postmenopausal Osteoporosis","Postmenopausal Osteopenia","Primary Osteoporosis","Osteoporosis",[32,30,33,34,35,36,37],"Postmenopausal","Osteopenia","Denosumab","Ibandronate","Zoledronic acid","Discontinuation","NOT_YET_RECRUITING","2026-02-09",{"date":41,"type":42},"2026-02-12","ACTUAL",{"date":44,"type":21},"2026-03-17",{"date":46,"type":21},"2030-09-17",{"name":48,"class":49},"National Taiwan University Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":50},"100615735","vitamin-d-status-and-multi-omics-profiles-in-primary-osteoporosis-100615735","NCT07296471","Vitamin D Status and Multi-Omics Profiles in Primary Osteoporosis","An Observational Study to Explore the Associations Between Vitamin D Status and Genomic, Proteomic, and Metabolomic Profiles in Patients With Primary Osteoporosis","OP-MultiOmics","Inclusion Criteria:\n\n1. Healthy controls: Adults aged ≥18 years, with normal bone mineral density (BMD) confirmed by dual-energy X-ray absorptiometry (DXA), without a history of bone metabolic diseases, major organ dysfunction, or chronic inflammatory\u002Fautoimmune diseases.\n2. Osteoporotic patients: Adults aged ≥18 years, newly diagnosed with primary osteoporosis according to clinical criteria (T-score ≤ -2.5 SD by DXA), without serious complications that may affect study results.\n3. Participants willing and able to provide written informed consent and cooperate with study procedures, including blood and serum sample collection and clinical data recording.\n\nExclusion Criteria:\n\n1. Patients with secondary osteoporosis, including but not limited to osteoporosis caused by hyperparathyroidism, tumors, chronic kidney disease, liver cirrhosis, rheumatoid arthritis, or other autoimmune diseases.\n2. Individuals who have taken vitamin D supplements, anti-osteoporotic drugs, glucocorticoids, or other medications affecting vitamin D or bone metabolism within 3 months prior to enrollment.\n3. Pregnant or lactating women, or individuals with mental disorders preventing cooperation with study procedures.\n4. Individuals with acute infections, malignant tumors, or severe liver, kidney, cardiovascular, or cerebrovascular diseases that may affect study outcomes.\n5. Participants with a history of blood transfusion within 1 month prior to enrollment or those unable to provide peripheral blood samples as required.",true,"ALL","18 Years",{"count":63,"type":21},120,"OBSERVATIONAL","This observational study aims to explore the relationships between vitamin D status and genomic, proteomic, and metabolomic profiles in patients with primary osteoporosis.\n\nEligible participants are adults who are newly diagnosed with primary osteoporosis at Yichang Second People's Hospital. Blood samples will be collected at the initial diagnosis to analyze gene expression, protein levels, and metabolic profiles.\n\nParticipants will receive standard clinical treatment according to routine care, but no additional research sampling or follow-up will be performed.\n\nThe study seeks to identify molecular patterns associated with osteoporosis and improve understanding of patient responses to therapy.",[29],[29,68,69,70,71,72,73],"Vitamin D","Multi-omics","Transcriptomics","Proteomics","Metabolomics","Biomarkers","RECRUITING","2025-12-08",{"date":77,"type":42},"2025-12-22",{"date":79,"type":42},"2025-11-11",{"date":81,"type":21},"2027-11-30",{"name":83,"class":49},"Dr. Li Chen"]