[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624211":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":28,"armGroups":36,"interventions":49,"overallOfficials":28,"centralContacts":59,"locations":66,"responsibleParty":81,"collaborators":83,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":28,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":28,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":68,"whyStopped":28,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage change in bone mineral density (BMD)","Change in BMD at the lumbar spine, femoral neck, and total hip measured by dual-energy X-ray absorptiometry (DXA) from baseline to 24 months.\n\nBaseline is defined as the time point 6 months after the last dose of denosumab, immediately prior to initiation of sequential therapy. BMD measurements will be performed at 6, 12, 18, and 24 months after treatment initiation.","Baseline to 24 months after treatment initiation.",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"Change in bone turnover makers (BTM) level","Changes in serum bone turnover markers, including procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide of type I collagen (CTX), will be evaluated to assess bone metabolic activity following denosumab discontinuation and sequential therapy.\n\nMeasurements will be obtained at baseline and at 3, 6, 9, 12, 18, and 24 months after treatment initiation.","Baseline to 24 months",{"measure":19,"description":20,"timeFrame":17},"Change in visual Analogue Scale (VAS) score","The Visual Analogue Scale (VAS) for pain will be used to assess participants' self-reported pain intensity. The VAS score ranges from 0 to 10, higher scores indicate worse pain intensity, and lower scores indicate less pain.\n\nPain intensity of the lower back and lower extremities will be evaluated at baseline and every 6 months during follow-up.",{"measure":22,"description":23,"timeFrame":24},"Incidence of osteoporotic fractures","The occurrence and anatomical sites of osteoporotic fractures will be recorded throughout the study period.","During the intervention period, up to 24 months.",{"measure":26,"description":27,"timeFrame":24},"Incidence of adverse events (AEs) and serious adverse events (SAEs)","All AEs and SAEs will be recorded and evaluated throughout the study period to assess the safety of sequential therapy.",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE","Osteoporosis has been recognized by the World Health Organization (WHO) as the second most prevalent global epidemic disease, following coronary heart disease. Untreated osteoporosis may lead to a vicious cycle of recurrent fractures, resulting in disability and even mortality. In clinical practice, antiresorptive agents are commonly used as first-line therapy. Denosumab is widely preferred due to its convenient administration and potent suppression of bone turnover. However, its antiresorptive effect is reversible; discontinuation of denosumab is associated with rebound increases in bone turnover markers (BTMs) and rapid bone mineral density (BMD) loss. Therefore, subsequent antiresorptive therapy is required to prevent fracture occurrence. Zoledronic acid has been shown to effectively suppress post-denosumab rebound bone turnover and is currently considered the standard sequential treatment following denosumab discontinuation.\n\nThe objective of this study is to demonstrate that ibandronate, when used as a sequential therapy after denosumab discontinuation, provides protection comparable to zoledronic acid in patients with short-term denosumab exposure (\\\u003C 3 years). This study aims to generate preliminary clinical evidence to support future trials and to offer an alternative post-denosumab treatment strategy in clinical practice. Participants will receive one year of ibandronate or zoledronic acid therapy, initiated 6 months (± 1 week) after the last dose of denosumab, followed by a total of two years of follow-up. Eligible participants will be randomized in a 1:1 ratio, with an estimated sample size of 26 patients per group.",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Ibandronate group","EXPERIMENTAL","use Ibandronate 1 year and follow-up for 2 years",[42],"Drug: Ibandronate IV",{"label":44,"type":45,"description":46,"interventionNames":47},"Zoledronic acid group","ACTIVE_COMPARATOR","use Zoledronic acid 1 year and follow-up for 2 years",[48],"Drug: Zoledronic acid IV",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":28},"DRUG","Ibandronate IV","Ibandronate 3mg\u002F3months for 12 months",[38],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":28},"Zoledronic acid IV","Zoledronic acid 5mg\u002F1year for 12 months",[44],[60],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},"Fon-Yih Tsuang Clinical Associate Professor, Ph.D","CONTACT","886-2312-3456 Ext. 265956","886-911138400","k880113a@gmail.com",[67],{"facility":5,"status":68,"city":69,"state":28,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"RECRUITING","Taipei","100","Taiwan","TW",{"type":74,"coordinates":75},"Point",[76,77],121.52639,25.05306,{"lat":77,"lon":76},[80],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},{"type":82,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[84],{"name":85,"class":6},"National Taiwan University","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":97,"type":98},52,"ESTIMATED","INTERVENTIONAL",[101],"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.",[104,105,106,107],"Postmenopausal Osteoporosis","Postmenopausal Osteopenia","Primary Osteoporosis","Osteoporosis",[109,107,110,111,112,113,114],"Postmenopausal","Osteopenia","Denosumab","Ibandronate","Zoledronic acid","Discontinuation","2026-08-21",{"date":117,"type":118},"2026-08-25","ACTUAL",{"date":120,"type":118},"2026-08-20",{"date":122,"type":98},"2030-10-31",{"name":5,"class":6},1]