Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-04-09 @ 9:20 PM
Study NCT ID:
NCT00489905
Status:
COMPLETED
Last Update Posted:
2013-10-23
First Post:
2007-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-22', 'studyFirstSubmitDate': '2007-06-20', 'studyFirstSubmitQcDate': '2007-06-20', 'lastUpdatePostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density of lumber spine', 'timeFrame': '12 months after administration of zolderonic acid'}, {'measure': 'Bone mineral density of femoral neck', 'timeFrame': '12 months after administration of zolderonic acid'}], 'secondaryOutcomes': [{'measure': 'Change in serum creatinine, calcium, phosphate and alkaline phosphatase', 'timeFrame': 'From time of enrollment to 3 months after the last intervention'}, {'measure': 'Change in creatinine clearance', 'timeFrame': 'From time of enrollment to 3 months after the last intervention'}]}, 'conditionsModule': {'keywords': ['prostate cancer', 'bone mineral density'], 'conditions': ['Prostatic Neoplasms', 'Bone Density']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of zoledronic acid on bone mineral density in prostatic cancer patients currently receiving androgen deprivation therapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Prostate cancer patients aged between 50-80 who is having or will have ADT. Baseline BMD in between -2 standard deviation (SD) and mean of that among young adults.\n\nExclusion Criteria:\n\n* Patients with renal or liver problems, on calcium or other bisphosphonate therapy within six months before enrolling into the study.\n\nPatients who have:\n\n* Serum creatinine levels \\>212 µmol/L (2.4 mg/dL).\n* Creatinine clearance \\<50 ml/min.\n* WBC \\<4.0x109/L, Hgb \\<10 g/dL, platelets \\<140x109/L. Patients with known hypersensitivity to bisphosphonates. Patients with history of diseases with influence on bone metabolism, such as Page's disease of bone, primary hyperparathyroidism or osteoporosis."}, 'identificationModule': {'nctId': 'NCT00489905', 'briefTitle': 'Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Authority, Hong Kong'}, 'officialTitle': 'Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer', 'orgStudyIdInfo': {'id': 'CRE-2005.137-T'}, 'secondaryIdInfos': [{'id': 'HARECCTR0500010'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Zolderonic acid (Zometa)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Department of Urology, Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Chi Fai Ng, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Division of Urology, The Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}]}}}