OsteoporosisNCT00625599
Fractures in the Elderly Population of El Salvador at Hospital Zacamil: Exploring Knowledge, Causes, Risk Factors, and Outcomes
An observational study of Osteoporosis and Fractures in the Elderly, run by Edward Via Virginia College of Osteopathic Medicine at 2 sites in El Salvador.
Trial summary
As the population's life expectancy increases, fractures among the elderly in El Salvador are also increasing. There is currently limited data specific to the incidence and cause of fractures in the elderly within developing countries, such as El Salvador. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Fractures in the Elderly
- What is being tested?
- Osteoporosis Prevention Information
- How many people
- 400 participants
- Where
- 2 sitesEl Salvador
- Study dates
- Jan 2008to Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: There will be two populations for this study. Hospital patients, females and males, over the age of 45 that are admitted to the department of orthopedics at the Hospital Zacamil in San Salvador, El Salvador from January 2008 to April 2008 will represent one of the populations. All patients over the age of 45 presenting to the hospital due to an acute fracture will be invited to join the study. The individual's care will not be changed negatively or positively based on whether or not the individual decides to participate in this study. The second population group will be the university students, females and males, over the age of 18 participating in non-medical studies at the Evangelical University in February 2009. No student will be negatively affected by not participating in this study. There will be no positive or negative influence on the student's grade or course assessment from participating or choosing not to participate in this study.
Who may be able to join
- For the student population they must be over the age of 18 and a student in non-medical track studies.
- For the patient population they must be over the age of 45 and present to Hospital Zacamil with an acute fracture.
Who cannot join
- Not accepting the invitation to participate.
Trial locations and contacts
2 sites in 1 country.
El Salvador2 sites
Evangelical University
San Salvador
Hospital Zacamil
San Salvador
About this study
As the population's life expectancy increases, fractures among the elderly in El Salvador are also increasing. There is currently limited data specific to the incidence and cause of fractures in the elderly within developing countries, such as El Salvador. The problem of inadequate knowledge pertaining to bone health and osteoporosis among the elderly is contributing to this aging population's health issues. The purpose of this study is to investigate the incidence, prevalence, and risk factors effecting elderly patients admitted for fractures at the Hospital Zacamil in San Salvador, El Salvador. The study will also assess the current knowledge in two distinct populations on bone health and osteoporosis. The first population will be the patients over the age of 45 that present to Hospital Zacamil with acute fractures and are consulted by the department of orthopedics. The second population will consist of students at the Evangelical University over the age of 18 in non-medial track studies. All individuals will have to accept the invitation to participate in the study. In addition, educational materials will be developed on the prevention of fractures for medical professionals and for the elderly in El Salvador. The study objectives will determine incidence and prevalence of elderly fractures of patients over the age of 45 at Hospital Zacamil. Secondly, the study will look at demographic information, prevalent causes of fractures, treatment of the fractures, morbidity and mortality, and any complications that may arise in the fracture patients prior to their discharge from the hospital. Thirdly, the study will seek out the current level of knowledge on bone health, osteoporosis, and fracture prevention in the young, educated Salvadorians and patients over the age of 45 at Hospital Zacamil. Fourthly, the study will address the benefits of the information gained by use of educational materials with the patients and doctors of El Salvador.
Hypothesis One:
Fractures of the elderly at Hospital Zacamil are significantly associated with occurring at the hip, wrist, and vertebra in comparison to other fracture locations.
- Conditions
- Osteoporosis, Fractures in the Elderly
- Being tested
- Osteoporosis Prevention Information
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoporosis Prevention InformationOther
Primary investigator designed osteoporosis prevention information.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Salvadorian students at the Evangelical University in non-health track studies over the age of 18. The students must accept the invitation to participate along with signing the informed consent to be eligible. Receives: Other: Osteoporosis Prevention Information | |
| 2 | Patients over the age of 45 presenting to Hospital Zacamil with an acute fracture. Patients must accept the invitation to the study and sign the informed consent to be eligible. Receives: Other: Osteoporosis Prevention Information |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625599
- Sponsor's protocol ID
- Evcom-13
- Status last verified
- Jan 2008
- First submitted
- 19 Feb 2008
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractures in the Elderly Population of El Salvador at Hospital Zacamil: Exploring Knowledge, Causes, Risk Factors, and Outcomes
- ClinicalTrials.gov ID
- NCT00625599
- Acronym / sponsor ID
- Evcom-13
- Conditions
- Osteoporosis, Fractures in the Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 28 Feb 2008 (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.
As the population's life expectancy increases, fractures among the elderly in El Salvador are also increasing. There is currently limited data specific to the incidence and cause of fractures in the elderly within developing countries, such as El Salvador. The problem of inadequate knowledge pertaining to bone health and osteoporosis among the elderly is contributing to this aging population's health issues. The purpose of this study is to investigate the incidence, prevalence, and risk factors effecting elderly patients admitted for fractures at the Hospital Zacamil in San Salvador, El Salvador. The study will also assess the current knowledge in two distinct populations on bone health and osteoporosis. The first population will be the patients over the age of 45 that present to Hospital Zacamil with acute fractures and are consulted by the department of orthopedics. The second population will consist of students at the Evangelical University over the age of 18 in non-medial track studies. All individuals will have to accept the invitation to participate in the study. In addition, educational materials will be developed on the prevention of fractures for medical professionals and for the elderly in El Salvador. The study objectives will determine incidence and prevalence of elderly fractures of patients over the age of 45 at Hospital Zacamil. Secondly, the study will look at demographic information, prevalent causes of fractures, treatment of the fractures, morbidity and mortality, and any complications that may arise in the fracture patients prior to their discharge from the hospital. Thirdly, the study will seek out the current level of knowledge on bone health, osteoporosis, and fracture prevention in the young, educated Salvadorians and patients over the age of 45 at Hospital Zacamil. Fourthly, the study will address the benefits of the information gained by use of educational materials with the patients and doctors of El Salvador.
Hypothesis One:
Fractures of the elderly at Hospital Zacamil are significantly associated with occurring at the hip, wrist, and vertebra in comparison to other fracture locations.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Osteoporosis Prevention InformationSalvadorian students at the Evangelical University in non-health track studies over the age of 18. The students must accept the invitation to participate along with signing the informed consent to be eligible. |
| 2 | – | Other: Osteoporosis Prevention InformationPatients over the age of 45 presenting to Hospital Zacamil with an acute fracture. Patients must accept the invitation to the study and sign the informed consent to be eligible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- There will be two populations for this study. Hospital patients, females and males, over the age of 45 that are admitted to the department of orthopedics at the Hospital Zacamil in San Salvador, El Salvador from January 2008 to April 2008 will represent one of the populations. All patients over the age of 45 presenting to the hospital due to an acute fracture will be invited to join the study. The individual's care will not be changed negatively or positively based on whether or not the individual decides to participate in this study. The second population group will be the university students, females and males, over the age of 18 participating in non-medical studies at the Evangelical University in February 2009. No student will be negatively affected by not participating in this study. There will be no positive or negative influence on the student's grade or course assessment from participating or choosing not to participate in this study.
Key inclusion criteria (2 listed)
- For the student population they must be over the age of 18 and a student in non-medical track studies.
- For the patient population they must be over the age of 45 and present to Hospital Zacamil with an acute fracture.
Key exclusion criteria (1 listed)
- Not accepting the invitation to participate.
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 |
|---|---|---|
| Osteoporosis Prevention InformationPrimary investigator designed osteoporosis prevention information. | Other | 1, 2 |
Primary outcome
Not reported in the source record.
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 22 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Fractures in the Elderly, run by Edward Via Virginia College of Osteopathic Medicine at 2 sites in El Salvador.
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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in El Salvador. 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.
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 22 Jul 2019.