Clinical Value of Self-assessment Risk of Osteoporosis in Chinese

Completed

• Conditions: Osteoporosis
• Interventions: Other: questionaire

• Registration Number: NCT02594592
• Lead Sponsor: Hongmei Zhang

Brief Summary

This cross-sectional study aimed to validate the effectiveness of the combined use of the Osteoporosis Self-Assessment Tool for Asians (OSTA) and the One-Minute Osteoporosis Risk Test (IOF test) in a population from Wuhan, China.

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-10
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-30
• Last Update Submitted: 2015-10-30
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Younger Women	questionaire	Younger Women (age ≤ 55 years),complete questionaire
Older Men	questionaire	Older Men (age \> 55 years). complete questionaire
Younger Men	questionaire	Younger Men (age ≤ 55 years),complete questionaire
Older Women	questionaire	Older Women (age \> 55 years),complete questionaire

Primary Outcome Measures

Name	Time	Method
validate the effectiveness of the combined use of the Osteoporosis Self-Assessment Tool for Asians and the One-Minute Osteoporosis Risk Test	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.