[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582151":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":68,"collaborators":45,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":45,"enrollmentInfo":80,"targetDuration":45,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":52,"whyStopped":45,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Zoledronic acid","ACTIVE_COMPARATOR","Patients referred to Aarhus University Hospital (AUH) for PTX due to PHPT will be included prospectively. We aim to include 140 patients with PHPT - 70 patients in each group. Patients will be enrolled consecutively until the required number of participants have been achieved. Enrolled participants will be randomized to intervention (active medicine) or placebo group and receive either zoledronate or placebo (saline water) 2-4 weeks prior to PTX.",[13],"Drug: Zoledronic acid 4 mg",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Natriumklorid 9 mg\u002Fml, Fresenius Kabi",[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Zoledronic acid 4 mg","Product name\u002FEU MP number: Zoledronic Acid Oresund Pharma 4 mg\u002F100 ml infusionsvätska, lösning\u002FPRD8924813 (Test) Substance (name\u002F code): ZOLEDRONIC ACID\u002FSUB00176MIG Strength: Zoledronic Acid 0.04mg Pharmaceutical form: SOLUTION FOR INFUSION Route of administration: INFUSIÓN INTRAVENOSA Marketing authorisation status (MA number, MS where authorised etc): 52486 \u002F SE Modified in relation to MA: No Max Dosage: mg milligram(s) Duration of use: Week",[9],[26,27,28],"ZOL","Zoledronate","Zoledronate acid",{"type":21,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Natriumklorid 9 mg\u002Fml, Fresenius Kabi","Product name\u002FEU MP number: Natriumklorid \"Baxter\" ClearFlex 9 mg\u002Fml,infusionsvæske, opløsning\u002FPRD456031 (Placebo) Substance (name\u002F code): SODIUM CHLORIDE\u002FSUB12581MIG Strength: Sodium Chloride 0.9g \u002F 100mL Pharmaceutical form: SOLUTION FOR INFUSION Route of administration: INFUSIÓN INTRAVENOSA Marketing authorisation status (MA number, MS where authorised etc): 32466 \u002F DK Modified in relation to MA: No Max Dosage: ml millilitre(s) Duration of use: Week",[15],[34],"saline water",[36],{"name":37,"affiliation":38,"role":39},"Lars Rejnmark, Professor","Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Anne Louise Vandsø Svenningsen, MD","CONTACT","+45 60183895",null,"ansvnn@rm.dk",{"name":48,"role":43,"phone":45,"phoneExt":45,"email":49},"Henriette Ejlsmark Svensson, MD, PhD","henrkn@rm.dk",[51],{"facility":38,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Aarhus N","Central Region of Denmark","8200","Denmark","DK",{"type":59,"coordinates":60},"Point",[61,62],10.17317,56.20367,{"lat":62,"lon":61},[65,66,67],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},{"name":48,"role":43,"phone":45,"phoneExt":45,"email":45},{"name":42,"role":39,"phone":45,"phoneExt":45,"email":45},{"type":69,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100582151","phase-4-bisphosphonate-prior-to-parathyroidectomy-in-primary-hyperparathyroidism-100582151",false,"NCT06859580","Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism","Bisphosphonate vs. Placebo Prior to Parathyroidectomy in Primary Hyperparathyroidisme: A Randomized, Double-blinded Placebo-controlled Trial","ZOLPHPT","Inclusion Criteria:\n\n1. Postmenopausal females or males \\> 50 years\n2. A diagnosis of hyperparathyroid hypercalcemia due to sporadic PHPT referred to PTX\n3. aBMD T-score ≤ -1 at total hip, femoral neck, or lumbar spine\n4. 25-hydroxyvitamin D ≥ 50 nmol\u002Fl prior to randomization\n5. Willingness to undergo PTX\n\nExclusion Criteria:\n\n1. Known or suspected familial ethology (e.g., MEN1 or 2)\n2. Estimated glomerular filtration rate \\\u003C 35 ml\u002Fmin\n3. Known allergy to bisphosphonates\n4. Planned or recent (within the last 3 months) major dental procedures (e.g., jaw surgery or tooth extraction)\n5. Chronic or acute disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, cancer) or prior medications (e.g., lithium, glucocorticoids within the last year, antiresorptive or bone anabolic treatment within the last 3 years) known to affect bone metabolism.","ALL","50 Years",{"count":81,"type":82},140,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","This study is a randomized, double-blinded, placebo-controlled trial investigating the effects of zoledronic acid (ZOL) versus placebo in patients with primary hyperparathyroidism (PHPT) undergoing parathyroidectomy (PTX). PHPT is a common endocrine disorder associated with hypercalcemia, reduced bone mineral density (BMD), increased fracture risk, renal calcifications, and cardiovascular complications. While PTX remains the definitive treatment, the potential role of bisphosphonates in optimizing post-surgical outcomes remains unclear.\n\nThis trial aims to evaluate whether a single infusion of ZOL prior to PTX impacts bone health, cardiovascular parameters, and renal function one year post-surgery. The primary endpoint is the change in areal bone mineral density (aBMD) at the lumbar spine one year after PTX. Secondary endpoints include changes in aBMD at other skeletal sites, volumetric BMD, bone microarchitecture, bone turnover markers, coronary artery calcium score, arterial stiffness, and renal calcifications.\n\nA total of 140 postmenopausal women and men over 50 years with PHPT and low BMD will be enrolled and randomized to receive either ZOL or placebo 2-4 weeks before PTX. Participants will undergo extensive imaging, biochemical analysis, and cardiovascular assessments at baseline and one year post-surgery.\n\nThis study seeks to clarify whether ZOL improves post-surgical bone recovery or interferes with the natural bone remodeling process following PTX. Additionally, it will provide insight into the cardiovascular and renal effects of bisphosphonate therapy in PHPT patients. Findings may help guide treatment strategies for optimizing long-term skeletal and systemic health in this patient population.",[88],"Primary Hyperparathyroidism",[90,91,92],"zoledronate","parathyroidectomy","placebo","2025-03-20",{"date":95,"type":96},"2025-03-25","ACTUAL",{"date":98,"type":96},"2025-03-01",{"date":100,"type":82},"2028-02-01",{"name":5,"class":6},1]