[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652358":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":44,"centralContacts":49,"locations":58,"responsibleParty":192,"collaborators":195,"id":215,"slug":216,"hasResults":217,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":217,"sex":223,"minAge":224,"maxAge":34,"enrollmentInfo":225,"targetDuration":34,"studyType":228,"phases":229,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":242,"whyStopped":34,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},{"fullName":5,"class":6},"Sahlgrenska University Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Short-course Romosozumab Followed by Denosumab","EXPERIMENTAL","Participants will receive romosozumab 210 mg by subcutaneous injection at Baseline and Months 1 and 2, followed by denosumab 60 mg by subcutaneous injection at Months 3, 9, 15, and 21. Participants entering the optional extension will continue denosumab at Months 27, 33, 39, and 45, unless contraindicated or clinically inappropriate. All participants will receive daily calcium and vitamin D supplementation throughout the study.",[13,14,15],"Drug: Romosozumab","Dietary Supplement: Calcium 500 mg and Vitamin D3 800 IU","Drug: Denosumab",{"label":17,"type":18,"description":19,"interventionNames":20},"Zoledronic Acid","ACTIVE_COMPARATOR","Participants will receive zoledronic acid 5 mg by intravenous infusion at Baseline and Month 12. Participants entering the optional extension will receive additional infusions at Months 24 and 36, unless contraindicated or clinically inappropriate. All participants will receive daily calcium and vitamin D supplementation throughout the study.",[21,14],"Drug: Zoledronic Acid 5 MG in 5 ML Injection",[23,30,35,40],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Romosozumab","Romosozumab 210 mg will be administered by subcutaneous injection once monthly for 3 consecutive months. Each monthly dose consists of two consecutive 105 mg injections.",[9],[29],"Evenity",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Zoledronic Acid 5 MG in 5 ML Injection","Zoledronic acid 5 mg intravenously at Baseline and Month 12, with additional doses at Months 24 and 36 in the extension unless contraindicated or clinically inappropriate.",[17],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"DIETARY_SUPPLEMENT","Calcium 500 mg and Vitamin D3 800 IU","Calcium and vitamin D supplementation, using 500 mg elemental calcium plus 20 micrograms cholecalciferol daily for 24 months. Participants entering the optional extension will receive daily calcium and vitamin D supplementation throughout the study.",[9,17],{"type":24,"name":41,"description":42,"armGroupLabels":43,"otherNames":34},"Denosumab","Denosumab 60 mg by subcutaneous injection at Months 3, 9, 15, and 21. Participants entering the optional extension will continue denosumab at Months 27, 33, 39, and 45 unless contraindicated or clinically inappropriate.",[9],[45],{"name":46,"affiliation":47,"role":48},"Mattias Lorentzon, MD, PhD","Sahlgrenska University Hospital Mölndal, Västra Götalandsregionen and University of Gothenburg","PRINCIPAL_INVESTIGATOR",[50,54],{"name":46,"role":51,"phone":52,"phoneExt":34,"email":53},"CONTACT","+46313431979","mattias.lorentzon@medic.gu.se",{"name":55,"role":51,"phone":56,"phoneExt":34,"email":57},"Lena Silberberg, BSc","+46313421000","lena.silberberg@vgregion.se",[59,77,92,106,121,136,151,163,177],{"facility":60,"status":34,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Skåne Universitetssjukhus","Malmö","Skåne County","20502","Sweden","SE",{"type":67,"coordinates":68},"Point",[69,70],13.00073,55.60587,{"lat":70,"lon":69},[73],{"name":74,"role":51,"phone":75,"phoneExt":34,"email":76},"Kristina Åkesson, MD, PhD","+46 40 33 10 00","kristina.akesson@med.lu.se",{"facility":78,"status":34,"city":79,"state":80,"zip":81,"country":64,"countryCode":65,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Karolinska University Hospital Huddinge","Huddinge","Stockholm County","14186",{"type":67,"coordinates":83},[84,85],17.98192,59.23705,{"lat":85,"lon":84},[88],{"name":89,"role":51,"phone":90,"phoneExt":34,"email":91},"Bo Freyschuss, MD, PhD","+46 8123 800 00","bofreyschuss@outlook.com",{"facility":93,"status":34,"city":94,"state":80,"zip":95,"country":64,"countryCode":65,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Sabbatsbergs sjukhus","Stockholm","11361",{"type":67,"coordinates":97},[98,99],18.06871,59.32938,{"lat":99,"lon":98},[102],{"name":103,"role":51,"phone":104,"phoneExt":34,"email":105},"Kristina Ekstrand, MD","+468 123 380 00","kristina.ekstrand@regionstockholm.se",{"facility":107,"status":34,"city":108,"state":109,"zip":110,"country":64,"countryCode":65,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Akademiska sjukhuset","Uppsala","Uppsala County","751 85",{"type":67,"coordinates":112},[113,114],17.63889,59.85882,{"lat":114,"lon":113},[117],{"name":118,"role":51,"phone":119,"phoneExt":34,"email":120},"Andreas Kindmark, MD, PhD","+46 18 611 00 00","andreas.kindmark@medsci.uu.se",{"facility":122,"status":34,"city":123,"state":124,"zip":125,"country":64,"countryCode":65,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Norrlands universitetssjukhus","Umeå","Västerbotten County","90185",{"type":67,"coordinates":127},[128,129],20.25972,63.82842,{"lat":129,"lon":128},[132],{"name":133,"role":51,"phone":134,"phoneExt":34,"email":135},"Anna Ramnemark, MD, PhD","090-785 00 00","anna.ramnemark@regionvasterbotten.se",{"facility":137,"status":34,"city":138,"state":139,"zip":140,"country":64,"countryCode":65,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Sundsvalls sjukhus","Sundsvall","Västernorrland County","856 43",{"type":67,"coordinates":142},[143,144],17.3063,62.39129,{"lat":144,"lon":143},[147],{"name":148,"role":51,"phone":149,"phoneExt":34,"email":150},"Margareta Rödén, MD","+4660 18 10 00","margareta.berglund.roden@rvn.se",{"facility":152,"status":34,"city":153,"state":154,"zip":155,"country":64,"countryCode":65,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Sahlgrenska University Hospital Mölndal","Mölndal","Västra Götaland County","43180",{"type":67,"coordinates":157},[158,159],12.01378,57.6554,{"lat":159,"lon":158},[162],{"name":46,"role":51,"phone":52,"phoneExt":34,"email":53},{"facility":164,"status":34,"city":165,"state":154,"zip":166,"country":64,"countryCode":65,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Skaraborgs sjukhus","Skövde","54949",{"type":67,"coordinates":168},[169,170],13.84506,58.39118,{"lat":170,"lon":169},[173],{"name":174,"role":51,"phone":175,"phoneExt":34,"email":176},"Eric Bertholds, MD","+46 500 43 10 00","eric.bertholds@vgregion.se",{"facility":178,"status":34,"city":179,"state":180,"zip":181,"country":64,"countryCode":65,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Linköping University Hospital","Linköping","Östergötland County","58185",{"type":67,"coordinates":183},[184,185],15.62157,58.41086,{"lat":185,"lon":184},[188],{"name":189,"role":51,"phone":190,"phoneExt":34,"email":191},"Anna Spångeus, MD, PhD","+46 10 103 00 00","anna.spangeus@liu.se",{"type":48,"investigatorFullName":193,"investigatorTitle":194,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Mattias Lorentzon","Senior Consultant in Geriatric Medicine and Professor of Geriatric Medicine",[196,198,200,202,204,206,209,211,213],{"name":197,"class":6},"Uppsala University Hospital",{"name":199,"class":6},"Karolinska University Hospital",{"name":201,"class":6},"Norrlands University Hospital",{"name":203,"class":6},"Sundsvall Hospital",{"name":205,"class":6},"Skane University Hospital",{"name":207,"class":208},"Region Stockholm","OTHER_GOV",{"name":210,"class":208},"Skaraborg Hospital",{"name":212,"class":6},"University Hospital, Linkoeping",{"name":214,"class":6},"Göteborg University","100652358","phase-4-sequential-treatment-with-romosozumab-followed-by-denosumab-vs-zoledronic-acid-for-gains-in-hip-bmd-100652358",false,"NCT07772609","Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD","Short-course Romosozumab Followed by Denosumab Versus Zoledronic Acid: A Multicentre Randomized Active-controlled Trial in Postmenopausal Women at High Fracture Risk","STRONG-HIP","Inclusion Criteria:\n\n1. The subject is a postmenopausal woman aged 60 years or older at screening.\n2. The subject has provided written informed consent before any trial-specific procedure is performed.\n3. The subject has osteoporosis at screening defined as a T-score of -2.5 or lower at the total hip or lumbar spine (L1-L4) on central reader confirmed bone densitometry by DXA.\n4. The subject is at high fracture risk, defined by at least one of the following: a previous low-trauma fracture after age 50 years (excluding skull, face, fingers and toes); FRAX probability at or above the age-specific Swedish intervention threshold (using Nordic and Nordic borne calculations, as appropriate) in use at screening.\n5. Corrected plasma calcium or ionized calcium is within the local reference range before randomization.\n6. Serum 25-hydroxyvitamin D concentration ≥50 nmol\u002FL before randomization.\n7. Adequate renal function for zoledronic acid treatment, defined as creatinine clearance ≥35 mL\u002Fmin calculated using the clinical trial center specified calculation procedure (e.g. the Cockcroft-Gault equation) before randomization.\n8. The subject is able and willing, in the investigator's judgment, to comply with the trial procedures and attend scheduled visits.\n9. For participants entering the extension, separate written extension consent is obtained before any extension-specific procedure is performed.\n\nExclusion Criteria:\n\n1. Severe osteoporosis, defined as total hip or lumbar spine T-score \\\u003C -3.5 and\u002For prevalent grade 2 or grade 3 vertebral fracture.\n2. Previous myocardial infarction or stroke at any time before screening.\n3. Transient ischemic attack, unstable angina, coronary or major peripheral revascularization within 12 months before screening, decompensated heart failure, uncontrolled clinically relevant arrhythmia, or any cardiovascular condition that in the investigator's judgment confers unacceptably high risk of a major adverse cardiovascular event during study participation.\n4. Use of intravenous bisphosphonate therapy or teriparatide within 3 years before randomization.\n5. Use of oral bisphosphonate or denosumab within 12 months before randomization.\n6. Any previous use of romosozumab.\n7. Use of systemic estrogen, selective estrogen receptor modulator within 3 months.\n8. Use of oral glucocorticoids for more than 14 consecutive days during the 6 months before screening.\n9. Known metabolic bone disease other than postmenopausal osteoporosis, including but not limited to Pagets disease, osteomalacia, untreated hyperparathyroidism, osteogenesis imperfecta, or active renal osteodystrophy.\n10. Creatinine clearance below 35 mL\u002Fmin, rapidly deteriorating renal function, or another renal condition that makes zoledronic acid unsafe.\n11. Hypocalcaemia (ionized calcium \\\u003C1.15 mmol\u002Fl or total albumin corrected calcium of \\\u003C2.15 mmol\u002Fl) or vitamin D 25-OH-vit-D \\\u003C50nmol\u002Fl, not corrected before randomization.\n12. Unexplained serum alkaline phosphatase \\>2 times the local upper limit of normal.\n13. Malignancy within the last 5 years, except adequately treated basal-cell carcinoma of the skin, squamous-cell carcinoma in situ of the skin, or cervical carcinoma in situ.\n14. Current osteonecrosis of the jaw, unhealed oral or jaw lesions, active dental or jaw infection, or planned invasive dental extraction\u002Fimplant procedure that has not been completed and healed before randomization, if considered by the investigator to represent a contraindication or unacceptable risk for treatment with romosozumab, denosumab or zoledronic acid.\n15. Known hypersensitivity or contraindication to romosozumab, denosumab, zoledronic acid, calcium supplementation, or vitamin D supplementation that cannot be safely managed under the protocol.\n16. Inability to undergo protocol DXA\u002FVFA reliably, for example because of body habitus exceeding scanner limits, inability to position safely, or interfering hardware or artefacts that prevent valid endpoint assessment.\n17. Current participation, or recent participation within 30 days or five half-lives (whichever is longer), in another interventional clinical trial that could affect safety or data interpretation.\n18. Any other medical, psychiatric, social or logistical condition that, in the investigators opinion, makes participation unsafe or would compromise protocol adherence or data reliability.","FEMALE","60 Years",{"count":226,"type":227},216,"ESTIMATED","INTERVENTIONAL",[230],"PHASE4","Osteoporosis is associated with a high risk of fractures, disability, loss of independence, and excess mortality. Zoledronic acid is an established first-line treatment in Sweden, but many patients at high fracture risk remain at substantial residual fracture risk. Short-course treatment with romosozumab followed by denosumab produces large increases in bone mineral density, but has not been directly compared with zoledronic acid.\n\nSTRONG-HIP is a multicentre, randomized, active-controlled phase 4 trial in 216 postmenopausal women aged 60 years or older with osteoporosis and high fracture risk. Participants are randomized 1:1 to receive romosozumab 210 mg monthly for 3 months followed by denosumab 60 mg every 6 months, or zoledronic acid 5 mg intravenously at baseline and Month 12.\n\nThe primary objective is to determine whether the romosozumab-denosumab sequence produces a greater percentage increase in total hip bone mineral density from baseline to Month 24 than zoledronic acid. Secondary outcomes include total hip and lumbar spine BMD at earlier time points, vertebral and clinical fractures, bone turnover markers, safety, health-related quality of life, and health-economic outcomes. A mechanistic substudy will assess bone microarchitecture and estimated strength using HR-pQCT.\n\nParticipants are followed for 24 months in the main study and may enter an optional extension with follow-up to Month 48 to assess the durability of treatment effects.",[233],"Osteoporosis in Post-menopausal Women",[235,25,41,236,237,238,239,240,241],"Randomized controlled trial","High resolution peripheral computed tomography","Bone mineral density","Zoledronic acid","Postmenopausal","Osteoporosis","Fracture risk","NOT_YET_RECRUITING","2026-08-18",{"date":245,"type":246},"2026-08-19","ACTUAL",{"date":248,"type":227},"2027-01-11",{"date":250,"type":227},"2031-12-31",{"name":5,"class":6},9]