NCT00625599

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

July 22, 2019

Status Verified

January 1, 2008

Enrollment Period

3 months

First QC Date

February 19, 2008

Last Update Submit

July 18, 2019

Conditions

Study Arms (2)

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.

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.

Other: Osteoporosis Prevention Information

Interventions

Primary investigator designed osteoporosis prevention information.

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Not accepting the invitation to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Evangelical University

San Salvador, El Salvador

Location

Hospital Zacamil

San Salvador, El Salvador

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 22, 2019

Record last verified: 2008-01

Locations