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Trial record 11 of 1246 for:    "Osteoporosis"

Clinical Value of Self-assessment Risk of Osteoporosis in Chinese

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ClinicalTrials.gov Identifier: NCT02594592
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Hongmei Zhang, Wuhan Integrated Traditional Chinese and Western Medicine Hospital

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.

Condition or disease Intervention/treatment
Osteoporosis Other: questionaire

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 : Observational
Actual Enrollment : 389 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Combined Assessment of the Osteoporosis Self-assessment Tool for Asians and the One-Minute Osteoporosis Risk Test in a Wuhan Population
Study Start Date : January 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Younger Women
Younger Women (age ≤ 55 years),complete questionaire
Other: 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
Other: 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
Other: 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
Other: 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)




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate.
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.

Responsible Party: Hongmei Zhang, director of department of endocrinology, Wuhan Integrated Traditional Chinese and Western Medicine Hospital
ClinicalTrials.gov Identifier: NCT02594592     History of Changes
Other Study ID Numbers: WuhanITCWMH
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015

Keywords provided by Hongmei Zhang, Wuhan Integrated Traditional Chinese and Western Medicine Hospital:
Osteoporosis
Osteoporosis Self-Assessment Tool
One-Minute Osteoporosis Risk Test
Asians

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases