SchizophreniaNCT00540267
Bone Density in Patients With Schizophrenia
An observational study of Schizophrenia and Alcohol Abuse, run by Inje University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Alcohol Abuse
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: people with schizophrenia, gaed between 18-80 years, with no endocrine disorder
Who may be able to join
- DSM-IV diagnosis of schizophrenia
- Onset of illness more than 5 years.
Who cannot join
- No severe Medical and endocrinological disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Mineral Density in the Korean Patients With Chronic Schizophrenia With Alcohol Abuse
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.
Read the 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.
- Conditions
- Schizophrenia, Alcohol Abuse
- Being tested
- No Intervention
- Keywords
- Schizophrenia, Alcohol Abuse, Bone Density
- Medical subject headings
- Schizophrenia, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Chronic schizophrenia with aged 18-80 years Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of bone mineral density
Measured: cross sectional and prospective
Secondary outcomes (1)
The effects of Smoking and antipsychotic drug on BMD
Measured: Cross sectional Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Investigators
- Joo-Cheol Shim, MD,PhD, Study director, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540267
- Sponsor's protocol ID
- BMD07
- Other IDs
- Korea Health 21 R&D Project
- Status last verified
- Oct 2008
- First submitted
- 4 Oct 2007
- Last updated
- 4 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density in the Korean Patients With Chronic Schizophrenia With Alcohol Abuse
- ClinicalTrials.gov ID
- NCT00540267
- Acronym / sponsor ID
- BMD07
- Conditions
- Schizophrenia, Alcohol Abuse
- Keywords
- Schizophrenia, Alcohol Abuse, Bone Density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | – | Other: No InterventionChronic schizophrenia with aged 18-80 years |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- people with schizophrenia, gaed between 18-80 years, with no endocrine disorder
Key inclusion criteria (2 listed)
- DSM-IV diagnosis of schizophrenia
- Onset of illness more than 5 years.
Key exclusion criteria (1 listed)
- No severe Medical and endocrinological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | Schizophrenia |
Primary outcome
The change of bone mineral density
Time frame: cross sectional and prospective
1 secondary outcome
The effects of Smoking and antipsychotic drug on BMD
Time frame: Cross sectional Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo-Cheol Shim, MD,PhD study director
Inje University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Alcohol Abuse, run by Inje University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of bone mineral density (time frame: cross sectional and prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2008.