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Trial record 40 of 999 for:    BMD

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
Sponsor:
Information provided by (Responsible Party):
Yaşar Keskin, Bezmialem Vakif University

Brief Summary:
Our clinical study aimed to evaluate the prevalence of osteoporosis (OP) in patients with ankylosing spondylitis (AS) and to investigate the relationship between clinical, disease activity, physical function and disease duration, and bone mineral density (BMD).

Condition or disease
Ankylosing Spondylitis Osteoporosis BMD

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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


Group/Cohort
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



Primary Outcome Measures :
  1. 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.


  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who were admitted to the rheumatology clinic between 25 and 65 years of age and diagnosed as AS according to the modified New York diagnostic criteria were included
Criteria

Inclusion Criteria:

  • Patients diagnosed as AS according to the modified New York diagnostic criteria were included

Exclusion Criteria:

  • Patients previously diagnosed with OP,
  • Patients previously treated with OP,
  • Patients with bone fractures previously associated with OP,
  • Those using drugs that affect bone metabolism, metabolic bone diseases (Paget's -disease, osteomalacia, hyperparathyroidism),
  • Diabetes mellitus,
  • Hypothyroidism, hyperthyroidism,
  • Patients with kidney, liver and intestinal diseases,
  • Those using corticosteroids

Information from the National Library of Medicine

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


Locations
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Turkey
Bezmialem Vakif University
Istanbul, Fatih, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University

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Responsible Party: Yaşar Keskin, Department of Physical Medicine and Rehabilitation, Principal Investigator, Medical Doctor, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03866135     History of Changes
Other Study ID Numbers: 11594
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Osteoporosis
Spondylitis, Ankylosing
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Diseases, Infectious
Infection
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis