Bone Mineral Density, Disease Duration, and Activity in Ankylosing Spondylitis

NCT03866135 | Completed DMC

• 1 other identifier: 11594
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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).

Conditions

Ankylosing Spondylitis; Osteoporosis; BMD

Outcome Measures

Primary Outcomes (2)

• Bath ankylosing spondylitis disease index (BASDAI)

  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.

  up to 6 month

• Bath ankylosing spondylitis functional index (BASFI)

  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.

  up to 6 month

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Osteoporosis

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Bone Diseases, Metabolic; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Physical Medicine and Rehabilitation, Principal Investigator, Medical Doctor

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: July 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2019
• Last Updated: March 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)