Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-05 @ 11:37 AM
Study NCT ID:
NCT06472050
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2024-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Romosozumab Versus Denosumab in GIOP: a 2-year Extension Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557282', 'term': 'romosozumab'}, {'id': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2024-06-09', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in BMD at the lumbar spine', 'timeFrame': '24 more months after RCT completion', 'description': 'spine BMD'}], 'secondaryOutcomes': [{'measure': 'change in BMD at non-dominant hip and femoral neck', 'timeFrame': '24 more months after RCT completion', 'description': 'hip and femoral neck BMD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucocorticoids', 'osteoporosis', 'fracture', 'romosozumab', 'denosoumab', 'outcome'], 'conditions': ['Osteoporosis', 'Glucocorticoids Toxicity']}, 'descriptionModule': {'briefSummary': 'The investigators conducted an open-label randomized controlled trial (RCT) in chronic glucocorticoid (GC) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (ROMO) for 12 months followed by denosumab (DEN) for 12 more months vs DEN for 24 months throughout. Superiority of ROMO/DEN to DEN/DEN in raising the spine bone mineral density (BMD) was demonstrated at month 12 and month 24. The present study was to report the further BMD changes at 48 months (2 year extension) for those participants who were maintained on DEN treatment.', 'detailedDescription': 'The investigators conducted a pilot open-label 24-month randomized controlled trial (RCT) comparing the efficacy of romosozumab (ROMO) with denosumab (DEN) in moderate/high risk adult patients using long-term GCs (defined as a daily prednisolone dose of ≥5mg/day for ≥12 months). All patients had moderate to high risk of osteoporotic fracture as evidenced by at least one of the following: (1) a personal history of fragility/vertebral fracture; (2) dual energy X-ray absorptiometry (DXA) T score ≤-2.5 \\[age ≥40 years\\] or Z scores ≤-3.0 \\[age \\<40 years\\] at spine, hip or femoral neck; or (3) high risk of 10-year FRAX-estimated major fracture).\n\nOf the 70 patients enrolled, 63 completed the study. At month 12, the spine bone mineral density (BMD) increased significantly in both the ROMO and DEN groups. The spine BMD gain from month 0-12 was significantly greater in ROMO-treated patients (p\\<0.001). Although the hip BMD at month 12 also increased significantly in the ROMO and DEN groups, the BMD gain was not significantly different between the groups. At month 24, the spine BMD continued to increase in both the ROMO and DEN groups, and the BMD gain remained significantly greater in ROMO-treated patients.\n\nAs there are no long-term data on the sequential use of ROMO and DEN in patients with GIOP, the current 2-year extension study is planned to observe the BMD changes at the spine and the hip of patients in the two treatment groups at month 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients who are continued on 6-monthly subcutaneous injection of DEN in either the ROMO or DEN arms after month 24 in our original RCT\n2. Those who are willing to have a repeat DXA assessment at the end of 4 years.\n\nExclusion Criteria:\n\n1. patients who refuse to be maintained on denosumab after month 24;\n2. patients who are maintained on other anti-osteoporotic drugs after month 24; and\n3. patients in whom prednisolone is planned to be tapered or discontinued after month 24.'}, 'identificationModule': {'nctId': 'NCT06472050', 'briefTitle': 'Romosozumab Versus Denosumab in GIOP: a 2-year Extension Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tuen Mun Hospital'}, 'officialTitle': 'Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CIRB-2024-224-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Romosozumab/denosumab', 'description': 'Romosozumab for 12 months, then denosumab for 36 months', 'interventionNames': ['Drug: Romosozumab', 'Drug: Denosumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Denosumab/denosumab', 'description': 'Densoumab for 48 months', 'interventionNames': ['Drug: Denosumab']}], 'interventions': [{'name': 'Romosozumab', 'type': 'DRUG', 'otherNames': ['Evenity (brand names)'], 'description': 'osteoporosis treatment', 'armGroupLabels': ['Romosozumab/denosumab']}, {'name': 'Denosumab', 'type': 'DRUG', 'otherNames': ['Prolia (brand name)'], 'description': 'osteoporosis treatment', 'armGroupLabels': ['Denosumab/denosumab', 'Romosozumab/denosumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chi Chiu Mok, MD, FRCP', 'role': 'CONTACT', 'email': 'ccmok2006@gmail.com', 'phone': '(852) 2468 5386'}, {'name': 'Chi Chiu Mok, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Medicine, Tuen Mun Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Chi Chiu Mok, MD, FRCP', 'role': 'CONTACT', 'email': 'ccmok2005@yahoo.com', 'phone': '852-37677844'}], 'overallOfficials': [{'name': 'Chi Chiu Mok, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tuen Mun Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuen Mun Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant and honorary professor', 'investigatorFullName': 'Chi Chiu Mok', 'investigatorAffiliation': 'Tuen Mun Hospital'}}}}