Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 9:35 PM
Study NCT ID:
NCT06164795
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2023-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential Therapies After Osteoanabolic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077211', 'term': 'Zoledronic Acid'}, {'id': 'D000069448', 'term': 'Denosumab'}, {'id': 'D019379', 'term': 'Teriparatide'}, {'id': 'C557282', 'term': 'romosozumab'}, {'id': 'C469775', 'term': 'Romo-A'}, {'id': 'C000596789', 'term': 'abaloparatide'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum samples for bone markers measurements'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2023-12-02', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lumbar spine bone mineral density', 'timeFrame': 'baseline to 12 months', 'description': 'bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)'}], 'secondaryOutcomes': [{'measure': 'femoral neck bone mineral density', 'timeFrame': 'baseline to 12 months', 'description': 'bone mineral density changes at the femoral neck at 12 months measured by dual-energy absorptiometry (DXA)'}, {'measure': 'total hip bone mineral density', 'timeFrame': 'baseline to 12 months', 'description': 'bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA)'}, {'measure': 'P1NP', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': 'bone turnover (formation) marker'}, {'measure': 'CTx', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': 'bone turnover (resorption) marker'}, {'measure': 'Fractures', 'timeFrame': '12 months', 'description': 'incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis, Postmenopausal']}, 'descriptionModule': {'briefSummary': '12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics', 'detailedDescription': 'Caucasian women with severe postmenopausal osteoporosis who have completed their course with romosozumab or a PTH analog will be assigned to one of the following 3 options: i) zoledronate 5mg infusion or ii) denosumab subcutaneous injections or iii) teriparatide or abaloparatide (for those previously treated with romosozumab) or romosozumab (for those previously treated with teriparatide or abaloparatide).\n\nEndpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; ii) changes at levels of bone turnover markers throughout the study; iii) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women treated with severe osteoporosis', 'genderDescription': 'Postmenopausal women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide\n\nExclusion Criteria:\n\n* a bone disease other than postmenopausal osteoporosis\n* use of medications other than romosozumab or teriparatide affecting bone metabolism during the last 12 months before entering the study\n* creatinine clearance \\<60 mL/min/1.73 m2\n* liver failure\n* any type of cancer\n* uncontrolled endocrine diseases\n* serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L)\n* hypersensitivity to denosumab or zoledronate or teriparatide or romosozumab or any of the excipients'}, 'identificationModule': {'nctId': 'NCT06164795', 'acronym': 'START', 'briefTitle': 'Sequential Therapies After Osteoanabolic Treatment', 'organization': {'class': 'OTHER', 'fullName': '424 General Military Hospital'}, 'officialTitle': 'Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide/Abaloparatide (START) Study', 'orgStudyIdInfo': {'id': 'START'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Romo-Zol group', 'description': 'Postmenopausal women treated with romosozumab for 12 months will receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose', 'interventionNames': ['Drug: Zoledronate']}, {'label': 'Romo-Dmab group', 'description': 'Postmenopausal women treated with romosozumab for 12 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months starting at 1 month after the last romosozumab dose', 'interventionNames': ['Drug: Denosumab']}, {'label': 'Romo-PTH group', 'description': 'Postmenopausal women treated with romosozumab for 12 months will receive daily injections of teriparatide 20μg or abaloparatide 80μg for 12 months starting at 1 month after the last romosozumab dose', 'interventionNames': ['Drug: Teriparatide', 'Drug: Abaloparatide Injection (80 mcg)']}, {'label': 'PTH-Zol group', 'description': 'Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 monthswill receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose', 'interventionNames': ['Drug: Zoledronate']}, {'label': 'PTH-Dmab group', 'description': 'Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months', 'interventionNames': ['Drug: Denosumab']}, {'label': 'TPTD-Romo group', 'description': 'Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive month injections of romosozumab for 12 months', 'interventionNames': ['Drug: Romosozumab']}], 'interventions': [{'name': 'Zoledronate', 'type': 'DRUG', 'otherNames': ['zoledronic acid; zolendronate'], 'description': 'intravenous infusion', 'armGroupLabels': ['PTH-Zol group', 'Romo-Zol group']}, {'name': 'Denosumab', 'type': 'DRUG', 'otherNames': ['Dmab'], 'description': 'subcutaneous injection', 'armGroupLabels': ['PTH-Dmab group', 'Romo-Dmab group']}, {'name': 'Teriparatide', 'type': 'DRUG', 'otherNames': ['TPTD'], 'description': 'subcutaneous injection', 'armGroupLabels': ['Romo-PTH group']}, {'name': 'Romosozumab', 'type': 'DRUG', 'otherNames': ['Romo'], 'description': 'subcutaneous injection', 'armGroupLabels': ['TPTD-Romo group']}, {'name': 'Abaloparatide Injection (80 mcg)', 'type': 'DRUG', 'description': 'daily subcutaneous injection', 'armGroupLabels': ['Romo-PTH group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11525', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Polyzois Makras, PhD', 'role': 'CONTACT', 'email': 'pmakras@gmail.com', 'phone': '+302107463606'}], 'facility': '251 Airforce & VA General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Maria P Yavropoulou, Consultant', 'role': 'CONTACT', 'email': 'myavropoulou@med.uoa.gr', 'phone': '+30 2132060800'}], 'facility': 'First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '14561', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Symeon Tournis, PhD', 'role': 'CONTACT', 'email': 'stournis@med.uoa.gr', 'phone': '+30 2132086000'}], 'facility': ', KAT General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '56429', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Athanasios D Anastasilakis, PhD', 'role': 'CONTACT', 'email': 'a.anastasilakis@gmail.com', 'phone': '+302310381697'}, {'name': 'Stergios A Polyzos, PhD', 'role': 'CONTACT', 'email': 'stergios@endo.gr', 'phone': '+302310455780'}], 'facility': '424 General Military Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristina Eller-Vainicher', 'role': 'CONTACT', 'email': 'eller.vainicher@gmail.com'}, {'name': 'Giorgia Grassi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00128', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Palermo, Ass Prof', 'role': 'CONTACT', 'email': 'A.Palermo@unicampus.it'}, {'name': 'Gaia Tabacco, PhD', 'role': 'CONTACT'}, {'name': 'Anda Naciu, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gaia Tabacco, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Campus Bio-Medico University', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '53100', 'city': 'Siena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Gennari, prof', 'role': 'CONTACT', 'email': 'gennari@unisi.it'}, {'name': 'Daniela Merlotti', 'role': 'CONTACT'}, {'name': 'Daniela Merlotti', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Medicine, Surgery and Neurosciences, University of Siena', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Vescini', 'role': 'CONTACT', 'email': 'fabio.vescini@asufc.sanita.fvg.it'}, {'name': 'Antonio Salcuni', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University-Hospital S. Maria della Misericordia', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'centralContacts': [{'name': 'Athanasios D Anastasilakis, PhD', 'role': 'CONTACT', 'email': 'a.anastasilakis@gmail.com', 'phone': '2310381431', 'phoneExt': '+30'}, {'name': 'John Carey, Prof', 'role': 'CONTACT', 'email': 'john.j.carey@universityofgalway.ie'}], 'overallOfficials': [{'name': 'Willem Lems, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'ECTS Clinical Action Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '424 General Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Endocrinology', 'investigatorFullName': 'Athanasios D. Anastasilakis', 'investigatorAffiliation': '424 General Military Hospital'}}}}