Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-26 @ 9:37 AM
Study NCT ID:
NCT01303692
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2011-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of bone density before and after hormone therapy', 'timeFrame': '1 year'}, {'measure': 'comparison of bone density between GnRH agonist alone vs. CAB group', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value', 'timeFrame': '1 year'}, {'measure': 'correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value before and after hormone therapy', 'timeFrame': '1 year'}, {'measure': '1year comparison of FRAX score before and after hormonal therapy', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bone mineral loss', 'prostate cancer', 'GnRH agonist alone vs. GnRH agonist plus anti-androgen combination'], 'conditions': ['GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients']}, 'referencesModule': {'references': [{'pmid': '28262724', 'type': 'DERIVED', 'citation': 'Kim SH, Joung JY, Kim S, Rha KH, Kim HG, Kwak C, Lee JY, Jeon SS, Hong SK, Jeong H, Jo MK, You D, Jeong IG, Hong JH, Kim CS. Comparison of bone mineral loss by combined androgen block agonist versus GnRH in patients with prostate cancer: A 12 month-prospective observational study. Sci Rep. 2017 Mar 6;7:39562. doi: 10.1038/srep39562.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent', 'detailedDescription': 'MC MD'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Korean prostate cancer over 50 years old with pathological confirmation\n* Patients receiving GnRH antagonist or GnRH agonist plus anti- androgen combination within 6 months since starting.\n* Patients measured bone density level before starting to receive hormone therapies above.\n\nExclusion Criteria:\n\n* Patients who are treated other anti-osteoporosis drugs and who are treated bisphosphate due to BMD T score below -3.0.\n* Patients who are hard to be analysed by attach to other bone disease.\n* Patients who are hard to be analysed by limitation of chart record according to investigators'discretion."}, 'identificationModule': {'nctId': 'NCT01303692', 'briefTitle': 'Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent', 'orgStudyIdInfo': {'id': 'NIS-OKR-CAS-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Total of 250 prostate cancer patients receiving GnRH agonist'}, {'label': 'B', 'description': 'Total of 250 prostate cancer patients receiving GnRH agonist plus anti-androgen agent'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Joon Woo Bahn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}