Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-28 @ 12:13 PM
Study NCT ID:
NCT00738257
Status:
COMPLETED
Last Update Posted:
2010-05-17
First Post:
2008-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multicentre, Open-label Randomised Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'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': 'D000077268', 'term': 'Pamidronate'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'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': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'lastUpdateSubmitDate': '2010-05-14', 'studyFirstSubmitDate': '2008-08-18', 'studyFirstSubmitQcDate': '2008-08-19', 'lastUpdatePostDateStruct': {'date': '2010-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Renal', 'transplant,', 'pamidronate,', 'ciclosporin,', 'Ciclosporin A,', 'steroids,', 'bone mineral density,', 'fracture rates', 'immunosuppressive', 'regimen'], 'conditions': ['Bone Loss']}, 'referencesModule': {'references': [{'pmid': '19393473', 'type': 'DERIVED', 'citation': 'Walsh SB, Altmann P, Pattison J, Wilkie M, Yaqoob MM, Dudley C, Cockwell P, Sweny P, Banks LM, Hall-Craggs M, Noonan K, Andrews C, Cunningham J. Effect of pamidronate on bone loss after kidney transplantation: a randomized trial. Am J Kidney Dis. 2009 May;53(5):856-65. doi: 10.1053/j.ajkd.2008.11.036.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A and glucocorticoid based immunosuppressive regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. First or second kidney transplant recipients, aged 18-75 years, PTH \\> 150 pg/ml\n2. De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.\n\nExclusion Criteria:\n\n1. Previous or current bone disease unrelated to end stage renal failure.\n2. Patients with PTH \\< 150pg/ml who may be at risk of adynamic bone disease.\n3. Treatment at any time with a bisphosphonate.\n4. d. Calcitonin treatment during the previous month.\n5. Malignancy (current or history within last 5 years)\n6. Pregnancy or lactation, or women of childbearing potential unwilling to use an effective form of contraception for the 12 month duration of the study.\n\nProtocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00738257', 'acronym': 'SMART', 'briefTitle': 'A Prospective, Multicentre, Open-label Randomised Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 2 Year Prospective, Multicentre, Open-label, Randomised, Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients (With a PTH > 150pg/ml) on a Ciclosporin A and Glucocorticoid Based Immunosuppressive Regimen.', 'orgStudyIdInfo': {'id': 'NEO-GB-50'}, 'secondaryIdInfos': [{'id': 'ARE-GB-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parmidronate', 'interventionNames': ['Drug: Pamidronate']}], 'interventions': [{'name': 'Pamidronate', 'type': 'DRUG', 'armGroupLabels': ['Parmidronate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frimley', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.31667, 'lon': -0.74544}}], 'overallOfficials': [{'name': 'John Cunningham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal London Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}