Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-23 @ 12:38 PM
Study NCT ID:
NCT00540267
Status:
COMPLETED
Last Update Posted:
2008-11-04
First Post:
2007-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Density in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-03', 'studyFirstSubmitDate': '2007-10-04', 'studyFirstSubmitQcDate': '2007-10-04', 'lastUpdatePostDateStruct': {'date': '2008-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of bone mineral density', 'timeFrame': 'cross sectional and prospective'}], 'secondaryOutcomes': [{'measure': 'The effects of Smoking and antipsychotic drug on BMD', 'timeFrame': 'Cross sectional Study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Alcohol Abuse', 'Bone Density'], 'conditions': ['Schizophrenia', 'Alcohol Abuse']}, 'descriptionModule': {'briefSummary': 'People with chronic mental disorder such as schizophrenia and alcohol abuse are high risk groups for developing osteoporosis.\n\nTo evaluate the prevalence of bone mineral density in men patients with schizophrenia with alcohol abuse, the investigators will compare bone mineral density between patient with schizophrenia with and without alcohol abuse.', 'detailedDescription': 'People with schizophrenia has been known as a high risk groups for developing osteoporosis, because of lack of exercise, poor nutrition and high rate of smoking. Those with alcohol abuse may be higher risk group than one with schizophrenia without alcohol abuse, because they frequently have several medical problems such as liver dysfunction, Vitamin D deficiency, hyperparathyroidism and those medical condition increase risk for developing osteoporosis. Also alcohol itself can increase bone loss too by disturbing bone remodeling and enhancing bone fragility. To compare the prevalence of bone mineral density in patients with schizophrenia with alcohol abuse to those without alcohol problem, we will investigate BMD in large population of Korean patients with those illnesses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'people with schizophrenia, gaed between 18-80 years, with no endocrine disorder', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV diagnosis of schizophrenia\n* Onset of illness more than 5 years.\n\nExclusion Criteria:\n\n* No severe Medical and endocrinological disorder'}, 'identificationModule': {'nctId': 'NCT00540267', 'briefTitle': 'Bone Density in Patients With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Bone Mineral Density in the Korean Patients With Chronic Schizophrenia With Alcohol Abuse', 'orgStudyIdInfo': {'id': 'BMD07'}, 'secondaryIdInfos': [{'id': 'Korea Health 21 R&D Project'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Schizophrenia', 'description': 'Chronic schizophrenia with aged 18-80 years', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['Schizophrenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '614-735', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Joo-Cheol Shim', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Joo-Cheol Shim, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inje University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Joo Shim', 'oldOrganization': 'Imje University Busan Paik Hospital'}}}}