Bone Mineral Density, Disease Duration, and Activity in Ankylosing Spondylitis
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|ClinicalTrials.gov Identifier: NCT03866135|
Recruitment Status : Completed
First Posted : March 7, 2019
Last Update Posted : March 11, 2019
|Condition or disease|
|Ankylosing Spondylitis Osteoporosis BMD|
In this cross-sectional study, patients who were admitted to the rheumatology clinic between 18 and 65 years of age and diagnosed as AS according to the modified New York diagnostic criteria were included
Patients group was divided two part as patients with (group 1)and without (group 2) osteoporosis.
The patient's global rating scale is a self-assessed scale of the patient with a grade of 10 (1: very bad, 5: moderate, 10: very good). To assess the disease activity, Bath ankylosing spondylitis disease index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) were evaluated. BASDAI is a self-assessment scale used to determine disease activity in patients with AS.
Schober measurement was used to evaluate lumbar mobility of the patients. Chest expansions were measured in all patients.
Body mass index (BMI) was calculated as kg/height m2. Erythrocyte sedimentation rate (ESH mm / h), C-reactive protein (CRP mg / l) levels were measured in all patients.
BMD measurements were made by using dual-energy x-ray absorptiometry (DEXA) and lumbar vertebra (L1-4) and left femur (femoral neck and total) regions. DEXA measurements (GE / LUNAR DPX PRO) were performed and the results were recorded using standard T score. Bone mineral densities of patients were based on the World Health Organization (WHO) classification of a T score between -1 and -2.5 for osteopenia; and a score of -2.5 for osteoporosis.
|Study Type :||Observational|
|Actual Enrollment :||111 participants|
|Official Title:||The Relationship Between Bone Mineral Density, Disease Duration, and Activity in Patients With Ankylosing Spondylitis|
|Actual Study Start Date :||July 1, 2018|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||January 31, 2019|
patients with osteoporosis
Osteoporosis has been operationally defined on the basis of bone mineral density (BMD) assessment. According to the WHO criteria, osteoporosis is defined as a BMD that lies 2.5 standard deviations or more below the average value for young healthy women (a T-score of <-2.5 SD)
patients without osteoporosis
Bone mineral densities of patients were based on the World Health Organization (WHO) classification of a T score between -1 and -2.5 for osteopenia
- Bath ankylosing spondylitis disease index (BASDAI) [ Time Frame: up to 6 month ]
BASDAI, is a widely used patient-reported outcome to measure disease activity in AS. It comprises only six questions (Box 5.1).
The answers to these questions are scored on a 0-10 NRS, which are anchored by 0 ("none") to 10 ("very severe"). The BASDAI sum score is calculated by the sum of questions 1-4 plus mean of questions 5 and 6, the total then divided by 5. The sum score ranges from 0 to 10, higher values indicate more active disease.
- Bath ankylosing spondylitis functional index (BASFI) [ Time Frame: up to 6 month ]Bath Ankylosing Spondylitis Functional Index (BASFI): this is the most frequently used tool to asses function in AS. It contains 10 questions on activities of daily living, which are scored with a rating scale from 0 (no functional impairments) to 10 (maximal impairment). The sum score ranges from 0 to 10, with higher values indicating worse functioning.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866135
|Bezmialem Vakif University|
|Istanbul, Fatih, Turkey, 34093|