Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-27 @ 6:17 AM
Study NCT ID:
NCT02594592
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2015-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Value of Self-assessment Risk of Osteoporosis in Chinese
Sponsor:
Hongmei Zhang
Organization:
Study Overview
Official Title:
Combined Assessment of the Osteoporosis Self-assessment Tool for Asians and the One-Minute Osteoporosis Risk Test in a Wuhan Population
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: