Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT00172003
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077211', 'term': 'Zoledronic Acid'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of skeletal complications', 'timeFrame': 'continuous'}], 'secondaryOutcomes': [{'measure': 'Time to first skeletal complication', 'timeFrame': 'from first application of Zometa until confirmed skeletal related event (SRE)'}, {'measure': 'Bone pain', 'timeFrame': 'every 9 weeks'}, {'measure': 'Time to overall progression of disease', 'timeFrame': 'continuous'}, {'measure': 'Overall survival', 'timeFrame': 'continuous'}, {'measure': 'Bone turnover parameters', 'timeFrame': 'every 9 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Renal Cell Cancer', 'Bone metastasis', 'Skeletal related event', 'Renal Cell Cancer patients with bone metastasis'], 'conditions': ['Renal Cell Cancer', 'Neoplasm Metastasis']}, 'referencesModule': {'references': [{'pmid': '22704310', 'type': 'RESULT', 'citation': 'Tunn UW, Stenzl A, Schultze-Seemann W, Strauss A, Kindler M, Miller K, Wirth MP, Zantl N, Schulze M, May C, Ruebel A, Birkholz K, Gruenwald V. Positive effects of zoledronate on skeletal-related events in patients with renal cell cancer and bone metastases. Can J Urol. 2012 Jun;19(3):6261-7.'}]}, 'descriptionModule': {'briefSummary': 'It is the aim of this clinical study to evaluate the skeletal-related event rate under therapy with zoledronic acid in patients with renal cell cancer having at least one cancer-related bone lesion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A histologically confirmed diagnosis of renal cell carcinoma with none, one or, at maximum, 2 of the following risk factors:\n\n 1. Karnofsky performance status less than 80%\n 2. Lactate dehydrogenase greater than 1.5 times upper limit of normal\n 3. Hemoglobin less than lower limit of normal\n 4. Absence of nephrectomy\n* Patients must have evidence of at least one cancer-related bone lesion. If diagnosis of bone metastases in bone scan or magnetic resonance imaging (MRI)-QuickScan is unclear radiographic (X-ray, computed tomography \\[CT\\] or MRI) confirmation of at least one focus is required.\n* ECOG performance status of 0, 1 or 2.\n* Life expectancy of ≥ 6 months\n* Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value\n* Patient has given written informed consent prior to any study-specific procedures\n\nExclusion Criteria:\n\n* Only patients who received 3 or less applications of an i.v. Bisphosphonate in the past are eligible\n* Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) is allowed. However, other loci of bone metastasis must be present, which were not treated with radiation therapy and thus can be assessed for primary and secondary endpoints.\n* Abnormal renal function as evidenced by a calculated creatinine clearance \\< 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula: CrCl = \\[140-age (years)\\] x weight (kg) {x 0.85 for female patients} \\[72 x serum creatinine (mg/dL)\\]\n* Corrected (adjusted for serum albumin) serum calcium concentration \\< 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L)\n* Patients with clinically symptomatic brain metastases\n* History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism\n* Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG.\n* Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates\n* Pregnancy and lactation\n* Women of childbearing potential not on a medically recognized form of contraception (i.e., oral contraceptives or implants, intrauterine device \\[IUD\\], vaginal diaphragm or sponge, or condom with spermicide)\n* Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion\n* Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion\n* Participation in another trial\n* Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)\n* Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study\n* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.\n* Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)\n\nOther protocol-defined inclusion and exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT00172003', 'briefTitle': 'Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis', 'orgStudyIdInfo': {'id': 'CZOL446EDE15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zoledronic acid', 'description': 'Zoledronic acid, dosage according to calculated creatinine clearance, administered as a 15 minute infusion every 3 weeks for 12 months. Study infusion visits should occur not earlier than the scheduled visit and no later than 3 days after the scheduled visit. The dose of zoledronic acid in patients with baseline creatinine clearance \\> 60 mL/min was recommended to be 4 mg infused over no less than 15 minutes.', 'interventionNames': ['Drug: Zoledronic acid']}], 'interventions': [{'name': 'Zoledronic acid', 'type': 'DRUG', 'armGroupLabels': ['Zoledronic acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Offenbach', 'country': 'Germany', 'facility': 'Novartis investigative Site', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmeceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}