Clinical Value of Self-assessment Risk of Osteoporosis in Chinese

NCT ID: NCT02594592

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 389 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-05-31

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.

Conditions

Osteoporosis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Younger Women

Younger Women (age ≤ 55 years),complete questionaire

questionaire

Intervention Type: OTHER

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

questionaire

Intervention Type: OTHER

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

questionaire

Intervention Type: OTHER

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

questionaire

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hongmei Zhang

OTHER

Sponsor Role: lead

Responsible Party

Hongmei Zhang

director of department of endocrinology

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

WuhanITCWMH

Identifier Type: -

Identifier Source: org_study_id