Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 2:23 AM
Study NCT ID:
NCT00381368
Status:
UNKNOWN
Last Update Posted:
2006-12-04
First Post:
2006-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077557', 'term': 'Ibandronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'lastUpdateSubmitDate': '2006-12-01', 'studyFirstSubmitDate': '2006-09-25', 'studyFirstSubmitQcDate': '2006-09-25', 'lastUpdatePostDateStruct': {'date': '2006-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Worst and average pain in movement and rest on the visual analogue scale (VAS) before the first dose, on days 2, 3, 7 and on day 28'}, {'measure': 'Analgesic consumption during the same period will additionally be assessed'}], 'secondaryOutcomes': [{'measure': 'Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28'}, {'measure': 'World Health Organization (WHO) performance status'}, {'measure': 'Safety: serum cystatin C and serum creatinine, and reporting of adverse events'}]}, 'conditionsModule': {'keywords': ['breast cancer', 'skeletal metastases', 'bisphosphonate therapy', 'Breast cancer with painful skeletal metastases'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.', 'detailedDescription': 'Painful skeletal metastases are a common site of advanced disease. For instance, in breast cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate treatment of pain), the patients often need additional treatments that may relieve their symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a significant decrease in pain scores, both after loading dose and after long-term treatment. In this study the safety and efficacy of an intravenous loading dose of three times 6 mg ibandronate during three consecutive days in breast cancer patients with painful skeletal metastases will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer with presence of bone metastases\n* Pain score over 4 on the VAS\n\nExclusion Criteria:\n\n* Patients with pathological fractures or medulla compression or neuropathic pain\n* Patients with infection or corticosteroid treatment\n* Pregnant or lactating patients'}, 'identificationModule': {'nctId': 'NCT00381368', 'briefTitle': 'Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': 'Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases', 'orgStudyIdInfo': {'id': 'ML20115'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2006-000697-74'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ibandronic acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'state': 'Helsinki', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Tiina Saarto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept of Oncology, Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '90029', 'city': 'Oulu', 'state': 'Oulu', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Arja Jukkola, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept of Oncology, Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '33521', 'city': 'Tampere', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Pirkko Kellokumpu-Lehtinen, PhD, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept of Oncology, Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'centralContacts': [{'name': 'Outi Paija, MD, PhD', 'role': 'CONTACT', 'email': 'outi.paija@tyks.fi', 'phone': '+358-2-3130000', 'phoneExt': '52863'}, {'name': 'Tiina Saarto, MD, PhD', 'role': 'CONTACT', 'email': 'tiina.saarto@hus.fi'}], 'overallOfficials': [{'name': 'Outi Paija, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Oncology, Turku University Hospital, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}]}}}