Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-30 @ 12:37 PM
Study NCT ID:
NCT01465568
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2011-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069448', 'term': 'Denosumab'}, {'id': 'D004164', 'term': 'Diphosphonates'}], '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'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-11', 'studyFirstSubmitDate': '2011-10-30', 'studyFirstSubmitQcDate': '2011-11-04', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone mineral density (BMD) changes at the lumbar spine', 'timeFrame': 'baseline, 6 months and 12 months'}], 'secondaryOutcomes': [{'measure': 'BMD changes in the total hip and femoral neck', 'timeFrame': 'baseline, 6 months and 12 months'}, {'measure': 'bone turnover markers', 'timeFrame': 'baseline, 6 months and 12 months'}, {'measure': 'New vertebral fractures', 'timeFrame': '12 months'}, {'measure': 'adverse events', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['osteoporosis', 'denosumab', 'RANKL', 'glucocorticoids'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '25761434', 'type': 'DERIVED', 'citation': 'Mok CC, Ho LY, Ma KM. Switching of oral bisphosphonates to denosumab in chronic glucocorticoid users: a 12-month randomized controlled trial. Bone. 2015 Jun;75:222-8. doi: 10.1016/j.bone.2015.03.002. Epub 2015 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment of osteoporosis in patients using bisphosphonates.', 'detailedDescription': 'There are no data on the use of denosumab in steroid induced osteoporosis. Postmenopausal women with chronic use of Glucocorticoid (GCs) are at high-risk of osteoporotic fractures. Despite bisphosphonate treatment, a certain proportion of high-risk patients using chronic GCs either do not achieve a satisfactory gain in bone mineral density (BMD) or develop new fragility fractures. Thus, more potent osteoporosis treatment is necessary for this subgroup of patients. This prompts the current study which aims to examine the efficacy of denosumab in current users of oral bisphosphonates for Glucocorticoid-induced Osteoporosis (GIOP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Women or adult men (\\>18 years of age) with various medical diseases requiring long-term prednisolone treatment. Pre-menopausal women should have no plan for pregnancy within 2 years of study entry and agree to practice contraception during this 2-year period.\n2. A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry.\n3. Having received oral bisphosphonate treatment for at least 2 years.\n4. Suboptimal response to bisphosphonate treatment, defined as either one of the following: (1) failure of lumbar spine, femoral neck or total hip BMD values to increase; (2) values of lumbar spine, femoral neck or total hip BMD remain osteoporotic, ie. T scores \\< -2.5 or Z scores \\< -2.0; or (3) development of new fragility vertebral or non-vertebral fractures despite at least 2 years' treatment with good compliance.\n5. Informed consent from patients.\n\nExclusion Criteria:\n\n1. Patients with previous use of denosumab or teriparatide.\n2. Premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period.\n3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.\n4. Patients with unexplained hypocalcemia.\n5. Patients with serum creatinine level of \\>=200umol/L."}, 'identificationModule': {'nctId': 'NCT01465568', 'briefTitle': 'Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tuen Mun Hospital'}, 'officialTitle': 'Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CREC/984/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Denosumab', 'description': 'denosumab', 'interventionNames': ['Drug: Denosumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bisphosphonates', 'description': 'continuation of bisphosphonates', 'interventionNames': ['Drug: bisphosphonates']}], 'interventions': [{'name': 'Denosumab', 'type': 'DRUG', 'otherNames': ['Prolia'], 'description': '60mg subcutaneous injection 6 monthly for 2 doses', 'armGroupLabels': ['Denosumab']}, {'name': 'bisphosphonates', 'type': 'DRUG', 'otherNames': ['continuation of bisphosphonates in their usual dosages'], 'description': 'continue present bisphosphonate treatment', 'armGroupLabels': ['bisphosphonates']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Tuen Mun Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], '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', 'investigatorFullName': 'Chi Chiu Mok', 'investigatorAffiliation': 'Tuen Mun Hospital'}}}}