NCT02594592

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

October 19, 2015

Last Update Submit

October 30, 2015

Conditions

Keywords

OsteoporosisOsteoporosis Self-Assessment ToolOne-Minute Osteoporosis Risk TestAsians

Outcome Measures

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

    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.

    1 day

Study Arms (4)

Younger Women

Younger Women (age ≤ 55 years),complete questionaire

Other: questionaire

Younger Men

Younger Men (age ≤ 55 years),complete questionaire

Other: questionaire

Older Men

Older Men (age \> 55 years). complete questionaire

Other: questionaire

Older Women

Older Women (age \> 55 years),complete questionaire

Other: questionaire

Interventions

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 MenOlder WomenYounger MenYounger Women

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate.

You may qualify if:

  • age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director of department of endocrinology

Study Record Dates

First Submitted

October 19, 2015

First Posted

November 3, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-10