- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02594592
Clinical Value of Self-assessment Risk of Osteoporosis in Chinese
Combined Assessment of the Osteoporosis Self-assessment Tool for Asians and the One-Minute Osteoporosis Risk Test in a Wuhan Population
Study Overview
Detailed Description
This cross-sectional study was a field investigation. A total of 400 Wuhan residents who visited the Health Examination Department at our hospital were invited to participate in this study. Potential participants were informed of the aim and procedures and were asked to sign an informed consent form before participation. Inclusion criteria were as follows: age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate. Exclusion criteria were as follows: severe liver, heart, or kidney impairment, and tumor. Procedures of the study were in accordance with the Declaration of Helsinki and were approved by the local ethics committee.
The study population was divided into four groups according to age and sex: Younger Women (age ≤ 55 years), Younger Men (age ≤ 55 years), Older Women (age > 55 years), and Older Men (age > 55 years). A research assistant and a nurse distributed the Chinese version of the IOF test to participants. The Chinese version of the IOF test includes 10 questions, two of which are specific to women and one to men. The maximum number of risk factors is 8 for women and 9 for men. Individuals were regarded as susceptible to osteoporosis risk if they answered "yes" to any of the 10 questions.
To assess the grade of osteoporosis risk, the OSTA index was calculated by the equation (body weight (kg) - age (years))*0.2. An OSTA index of -1 to -4 is regarded as medium risk, greater than -1 as low risk, and less than -4 as high risk.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate.
Exclusion Criteria:
- severe liver, heart, or kidney impairment, and tumor. Procedures of the study were in accordance with the Declaration of Helsinki and were approved by the local ethics committee.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Younger Women
Younger Women (age ≤ 55 years),complete questionaire
|
Arm: Experimental :questionaire medium risk, and high risk.(more
than one positive answer about questionaire) Arm:Active Comparator: questionaire low risk (none of positive answer about questionaire)
|
|
Younger Men
Younger Men (age ≤ 55 years),complete questionaire
|
Arm: Experimental :questionaire medium risk, and high risk.(more
than one positive answer about questionaire) Arm:Active Comparator: questionaire low risk (none of positive answer about questionaire)
|
|
Older Men
Older Men (age > 55 years).
complete questionaire
|
Arm: Experimental :questionaire medium risk, and high risk.(more
than one positive answer about questionaire) Arm:Active Comparator: questionaire low risk (none of positive answer about questionaire)
|
|
Older Women
Older Women (age > 55 years),complete questionaire
|
Arm: Experimental :questionaire medium risk, and high risk.(more
than one positive answer about questionaire) Arm:Active Comparator: questionaire low risk (none of positive answer about questionaire)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
validate the effectiveness of the combined use of the Osteoporosis Self-Assessment Tool for Asians and the One-Minute Osteoporosis Risk Test
Time Frame: 1 day
|
The IOF test were filled out by participants.
The Chinese version of the IOF test includes 10 questions, two of which are specific to women and one to men.
The maximum number of risk factors is 8 for women and 9 for men.
Individuals were regarded as susceptible to osteoporosis risk if they answered "yes" to any of the 10 questions.The OSTA index was calculated by the equation (body weight (kg) - age (years))*0.2.
weight in kilograms.
age in years.An OSTA index of -1 to -4 is regarded as medium risk, greater than -1 as low risk, and less than -4 as high risk.
Then detect any association between the results of IOF test and the risk grade.
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WuhanITCWMH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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