Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-28 @ 2:50 AM
Study NCT ID:
NCT05575167
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2022-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
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': 'D019386', 'term': 'Alendronate'}, {'id': 'D002118', 'term': 'Calcium'}], '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': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, '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': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-08', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lumbar spine BMD', 'timeFrame': '24 months', 'description': 'BMD changes at the lumbar spine at 12 and 24 months'}], 'secondaryOutcomes': [{'measure': 'femoral neck BMD', 'timeFrame': '24 months', 'description': 'BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months'}, {'measure': 'P1NP', 'timeFrame': 'baseline, 3 months, 6 months, 12 months, 18 months, 24 months', 'description': 'bone turnover (formation) marker'}, {'measure': 'CTx', 'timeFrame': '24 months', 'description': 'bone turnover (resorption) marker'}, {'measure': 'fracture', 'timeFrame': '24 months', 'description': 'incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral'}, {'measure': 'height', 'timeFrame': '24 months', 'description': 'loss of height'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis, Postmenopausal']}, 'descriptionModule': {'briefSummary': 'A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab', 'detailedDescription': '125 postmenopausal women treated with Dmab for 3 or more years who will reach osteopenia with denosumab will be randomized into three groups: i) zoledronate infusion (5mg) at 6 months after last Dmab dose (single Zol group) ii) zoledronate infusion (5mg) at 6 and 12 months after last Dmab dose (double Zol group) iii) alendronate 70mg orally weekly for 12 months (ALN group) All women will receive no further treatment during the 2nd year of the study.\n\nParticipating centers: ECTS affiliated bone centers\n\nEndpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the lumbar spine at 24 months; ii) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; iii) changes at levels of bone turnover markers throughout the study; iv) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral; v) clinical parameters: height change, VAS for back pain, and use of analgesics'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women treated with denosumab', 'genderDescription': 'postmenopausal women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia\n\nExclusion Criteria:\n\n* a bone disease other than postmenopausal osteoporosis\n* use of medications other than bisphosphonates or SERMS 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)'}, 'identificationModule': {'nctId': 'NCT05575167', 'acronym': 'EURODEC', 'briefTitle': 'Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)', 'organization': {'class': 'OTHER', 'fullName': '424 General Military Hospital'}, 'officialTitle': 'The Effectiveness of Single or Repeat Zoledronate Infusion Versus Oral Alendronate in Consolidating the Bone Accrual Achieved With Denosumab: a Study Organised by the European Calcified Tissue Society', 'orgStudyIdInfo': {'id': 'EURODEC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single Zol group', 'description': 'postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive a single zoledronate infusion (5mg) at 6 months after the last denosumab dose', 'interventionNames': ['Drug: Zoledronate or Alendronate']}, {'label': 'double Zol group', 'description': 'postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive two zoledronate infusions (5mg) at 6 and 12 months after the last denosumab dose', 'interventionNames': ['Drug: Zoledronate or Alendronate']}, {'label': 'ALN group', 'description': 'postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive alendronate 70mg orally weekly for 12 months', 'interventionNames': ['Drug: Zoledronate or Alendronate']}], 'interventions': [{'name': 'Zoledronate or Alendronate', 'type': 'DRUG', 'otherNames': ['Calcium and vitamin D supplementation'], 'description': 'infusion (for zoledronate) or oral digestion (for alendronate)', 'armGroupLabels': ['ALN group', 'double Zol group', 'single Zol group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Paccou, Prof', 'role': 'CONTACT', 'email': 'Julien.PACCOU@chu-lille.fr'}], 'facility': 'Univ. Lille, CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '11525', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Polyzois Makras, PhD', 'role': 'CONTACT', 'email': 'pmakras@gail.com', 'phone': '+30 2107463606'}], 'facility': '251 Hellenic Airforce and 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': 'NOT_YET_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': 'NOT_YET_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': 'NOT_YET_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': 'NOT_YET_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, MD', 'role': 'CONTACT', 'email': 'a.anastasilakis@gmail.com', 'phone': '2310381431', 'phoneExt': '+30'}, {'name': 'John Carey, MD', 'role': 'CONTACT', 'email': 'john.j.carey@universityofgalway.ie'}], 'overallOfficials': [{'name': 'Willem Lems, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ECTS Clinical Action Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '424 General Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant of endocrinology; in charge of the Department of Metabolic Bone Diseases', 'investigatorFullName': 'Athanasios D. Anastasilakis', 'investigatorAffiliation': '424 General Military Hospital'}}}}