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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 389}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2015-10-19', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'validate the effectiveness of the combined use of the Osteoporosis Self-Assessment Tool for Asians and the One-Minute Osteoporosis Risk Test', 'timeFrame': '1 day', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Osteoporosis Self-Assessment Tool', 'One-Minute Osteoporosis Risk Test', 'Asians'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT02594592', 'briefTitle': 'Clinical Value of Self-assessment Risk of Osteoporosis in Chinese', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Integrated Traditional Chinese and Western Medicine Hospital'}, 'officialTitle': 'Combined Assessment of the Osteoporosis Self-assessment Tool for Asians and the One-Minute Osteoporosis Risk Test in a Wuhan Population', 'orgStudyIdInfo': {'id': 'WuhanITCWMH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Younger Women', 'description': 'Younger Women (age ≤ 55 years),complete questionaire', 'interventionNames': ['Other: questionaire']}, {'label': 'Younger Men', 'description': 'Younger Men (age ≤ 55 years),complete questionaire', 'interventionNames': ['Other: questionaire']}, {'label': 'Older Men', 'description': 'Older Men (age \\> 55 years). complete questionaire', 'interventionNames': ['Other: questionaire']}, {'label': 'Older Women', 'description': 'Older Women (age \\> 55 years),complete questionaire', 'interventionNames': ['Other: questionaire']}], 'interventions': [{'name': 'questionaire', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Older Men', 'Older Women', 'Younger Men', 'Younger Women']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hongmei Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'director of department of endocrinology', 'investigatorFullName': 'Hongmei Zhang', 'investigatorAffiliation': 'Wuhan Integrated Traditional Chinese and Western Medicine Hospital'}}}}