Bone Density in Patients With Schizophrenia
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 4, 2007 | ||||
| Last Updated Date | November 3, 2008 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The change of bone mineral density [ Time Frame: cross sectional and prospective ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00540267 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The effects of Smoking and antipsychotic drug on BMD [ Time Frame: Cross sectional Study ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bone Density in Patients With Schizophrenia | ||||
| Official Title ICMJE | Bone Mineral Density in the Korean Patients With Chronic Schizophrenia With Alcohol Abuse | ||||
| Brief Summary | People with chronic mental disorder such as schizophrenia and alcohol abuse are high risk groups for developing osteoporosis. To 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. |
||||
| Detailed Description | 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. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | people with schizophrenia, gaed between 18-80 years, with no endocrine disorder |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Other: No Intervention
No Intervention |
||||
| Study Group/Cohort (s) | Schizophrenia
Chronic schizophrenia with aged 18-80 years
Intervention: Other: No Intervention |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00540267 | ||||
| Other Study ID Numbers ICMJE | BMD07, Korea Health 21 R&D Project | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joo Shim, Imje University Busan Paik Hospital | ||||
| Study Sponsor ICMJE | Inje University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Inje University | ||||
| Verification Date | October 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||