Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT00632905
Status:
COMPLETED
Last Update Posted:
2017-09-28
First Post:
2008-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Health Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 599}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-27', 'studyFirstSubmitDate': '2008-02-20', 'studyFirstSubmitQcDate': '2008-03-04', 'lastUpdatePostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Mineral Density of the lumbar spine', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Overall Safety', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Prostatic adenoma', 'Prostatic neoplasm'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Prostate Cancer patients treated with LHRH agonists (e.g., goserelin) lose Bone Mineral Density (BMD). Using a prospective, observational study design, we propose that monitoring how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. The gold standard for evaluating BMD is dual energy x-ray absorptiometry (DEXA). The proposed study will provide some of the first prospective data on the rates of Skeletal Related Events (SREs) in prostate cancer patients undergoing ADT and help develop official guidelines on the use of DEXA screening for prostate cancer patients.', 'detailedDescription': 'A consequence of ADT is the gradual bone loss, so-called cancer treatment induced bone loss (CTIBL). The current standard of care is the addition of Vitamin D and Calcium upon the initiation of ADT. Moreover, bisphosphonates are now being considered to treat and prevent CTIBL. However, bisphosphonates are costly, thus there is a desire to identify or target a specific subset of patients who would most benefit from the treatment.\n\nBy obtaining baseline BMD and monitoring for Skeletal Related Events (SREs), we hope to identify that specific sub-set of patients who would most benefit from the treatment. Using a prospective, observational study design, we propose monitoring how physicians manage CTIBL in their patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinics', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients willing to provide written Informed Consent.\n* Patients for whom Androgen Deprivation Therapy (ADT) with Zoladex® is indicated for at least 1 year.\n* Patients started on Zoladex® within the last 4 months.\n\nExclusion Criteria:\n\n* Patient had surgery or significant traumatic injury occurring within 1 month prior to consent.\n* Known hypersensitivity to Goserelin Acetate or any of the components found in Zoladex®.\n* Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT00632905', 'acronym': 'BHOS', 'briefTitle': 'Bone Health Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'CMX Research'}, 'officialTitle': 'A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).', 'orgStudyIdInfo': {'id': 'AZ-CMX-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Normal - BMD with T-score at or above -1.0'}, {'label': '2', 'description': 'Osteopenic - BMD with T-score between -1.1 and -2.4'}, {'label': '3', 'description': 'Osteoporotic - BMD with T-score at or below -2.5'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5G 1T4', 'city': 'Burnaby', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. John A. Warner', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}, {'zip': 'V1Y 2H4', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Southern Interior Medical Research Corporation', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V9S 2B5', 'city': 'Nanaimo', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Nanaimo Urology Associates', 'geoPoint': {'lat': 49.16638, 'lon': -123.94003}}, {'zip': 'V9Y 8C8', 'city': 'Port Alberni', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Central Island Research Centre', 'geoPoint': {'lat': 49.24133, 'lon': -124.8028}}, {'zip': 'V3V 1N1', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Andreou Research', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'B4N 4K9', 'city': 'Kentville', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Bruce W. Palmer Urology Inc.', 'geoPoint': {'lat': 45.0771, 'lon': -64.49605}}, {'zip': 'L6V 1B4', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Jonathan L. Giddens', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'N3R 4N3', 'city': 'Brantford', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brantford Urology Research Medical Arts Bldg.', 'geoPoint': {'lat': 43.1334, 'lon': -80.26636}}, {'zip': 'L7N 3V2', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'G. Kenneth Jansz Medicine Professional Corporation', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'L7T 3K4', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Richard Sowery', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'P3E 4T3', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northern Urology Centre', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'N1H 5J1', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Guelph Urology Associates', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}, {'zip': 'K7L 3J7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Alvaro Morales', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'L6B 1A1', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GU Trials Markham', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'L3X 1W1', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mor Urology Inc', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'P1B 4Y3', 'city': 'North Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Medical & Dental Bldg', 'geoPoint': {'lat': 46.3168, 'lon': -79.46633}}, {'zip': 'M3B 3S6', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Stanley Flax Medicine Professional Corporation'}, {'zip': 'M3N 2V6', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'York-Finch Med Centre'}, {'zip': 'L6H 3P1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Fe/Male Health Centres', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'L3V 7V1', 'city': 'Orillia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Orillia Urology Associates', 'geoPoint': {'lat': 44.60868, 'lon': -79.42068}}, {'zip': 'L1H 1B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Urotec', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mahoney Medicine Professional Corporation', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'N4K 2J1', 'city': 'Owen Sound', 'state': 'Ontario', 'country': 'Canada', 'facility': '2150935 Ontario Inc', 'geoPoint': {'lat': 44.56717, 'lon': -80.94349}}, {'zip': 'K9H 1T6', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kawartha Urology Associates', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'K9J 2X5', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Medical Centre', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'M1S 4V5', 'city': 'Scarborough Village', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Allan Abramovitch', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'K7A 2H9', 'city': 'Smiths Falls', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Peter Roney', 'geoPoint': {'lat': 44.90452, 'lon': -76.02333}}, {'zip': 'P7E 6E7', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'West Arthur Place', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'M1P 2T7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Edward Woods', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6A 3B5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Male Health Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M2K 2W1', 'city': 'Willowdale', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Roger Buckley', 'geoPoint': {'lat': 43.76672, 'lon': -79.39909}}, {'zip': 'N8Y 4X9', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ABHM Associates', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'G7H 6B9', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dr. Louis-Rene Barrette', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'J2G 8Z9', 'city': 'Granby', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Recherches Cliniques Theradev', 'geoPoint': {'lat': 45.40008, 'lon': -72.73243}}, {'zip': 'H7G 2E6', 'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Polyclinique Med Concorde', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': 'H9R 4S3', 'city': 'Point Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Ultra-Med Inc.'}, {'zip': 'G7H 4A3', 'city': 'Saguenay', 'state': 'Quebec', 'country': 'Canada', 'facility': "Clinique d'Urologie du Saguenay", 'geoPoint': {'lat': 48.41675, 'lon': -71.06573}}, {'zip': 'J6E 6J2', 'city': 'Saint Charles-Baromee', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Récherche en Urologie de Lanaudiére'}, {'zip': 'H4A 1S9', 'city': 'Westmount', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Westmount Med Bldg', 'geoPoint': {'lat': 45.48341, 'lon': -73.59918}}, {'zip': 'S7K 3H3', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Medical Arts Bldg', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Richard W Casey, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CMX Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMX Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}