Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT05760105
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2023-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Awareness of Osteoporosis in Ankylosing Spondylosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], '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'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-20', 'studyFirstSubmitDate': '2023-02-26', 'studyFirstSubmitQcDate': '2023-02-26', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revised Osteoporosis Knowledge Test', 'timeFrame': '1 day', 'description': "The 32-item Revised Osteoporosis Knowledge Test (ROKT; 2012), as reported by Gendler et al. (2015), is a revision of the original 24-item OKT developed by Kim, Horan, \\& Gendler (1991). This measure was developed to assess the osteoporosis knowledge of adults. Changes were made to update the original OKT to include current recommendations for calcium and vitamin D, exercise requirements, diagnosis and treatment, and a more comprehensive understanding of bone development and osteoporosis risk factors. It contains two subscales (Nutrition and Exercise), which share 14 common items including risk factors and general knowledge. Although the responses offered to participants are multiple choice (e.g., for risk items: more likely, less likely, neutral, don't know), there is only one correct answer for each item. Responses are dichotomously recoded as correct or incorrect."}], 'secondaryOutcomes': [{'measure': 'Osteoporosis Self-Efficacy Scale', 'timeFrame': '1 day', 'description': "The Osteoporosis Self-Efficacy Scale (OSES) utilizes perceived susceptibility and seriousness, perceived barriers and benefits, health motivation, and self-confidence in one's ability to take actions needed to prevent osteoporosis to predict possible occurrence of health behaviors."}, {'measure': 'Osteoporosis Health Belief Scale', 'timeFrame': '1 day', 'description': 'The Osteoporosis Health Belief Scale (OHBS) is a 42-item questionnaire designed to assess susceptibility, seriousness, calcium benefits, calcium barriers, exercise benefits, exercise barriers, and health motivation related to osteoporosis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Osteoporosis Risk', 'Ankylosing Spondylitis']}, 'descriptionModule': {'briefSummary': 'Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Ankylosing spondylitis patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in ankylosing spondylitis patients.', 'detailedDescription': "Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with ankylosing spondylitis are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with ankylosing spondylitis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 to 90 years with a diagnosis of ankylosing spondylitis who gave consent to participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of ankylosing spondylitis\n* Must be between the ages of 18 and 99\n* Must give consent to participate in the study\n\nExclusion Criteria:\n\n• Not giving consent'}, 'identificationModule': {'nctId': 'NCT05760105', 'briefTitle': 'Awareness of Osteoporosis in Ankylosing Spondylosis Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Uskudar State Hospital'}, 'officialTitle': 'Awareness of Osteoporosis in Ankylosing Spondylosis Patients', 'orgStudyIdInfo': {'id': 'OPAS1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ankylosing Spondylitis Patients', 'description': 'Patients diagnosed with ankylosing spondylitis.', 'interventionNames': ['Other: Patient Participation Form']}], 'interventions': [{'name': 'Patient Participation Form', 'type': 'OTHER', 'description': 'A form that consists of revised osteoporosis knowledge test, osteoporosis self-efficacy scale, and osteoporosis health belief scale.', 'armGroupLabels': ['Ankylosing Spondylitis Patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mustafa H Temel, M.D.', 'role': 'CONTACT', 'email': 'mhuseyintemel@gmail.com', 'phone': '+905342714872'}, {'name': 'Emre Ata, M.D.', 'role': 'CONTACT', 'email': 'emreata.ftr@gmail.com', 'phone': '+905336152162'}], 'overallOfficials': [{'name': 'Mustafa H Temel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uskudar State Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data will be shared by corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar State Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mustafa Hüseyin Temel', 'investigatorAffiliation': 'Uskudar State Hospital'}}}}