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Completed

NCT Number: NCT02594592

Clinical Value of Self-assessment Risk of Osteoporosis in Chinese

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionaire

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)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hongmei Zhang

Other

Registry information

Official study title

Combined Assessment of the Osteoporosis Self-assessment Tool for Asians and the One-Minute Osteoporosis Risk Test in a Wuhan Population

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 3, 2015
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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