Clinical Trial of Osteoporosis in Ankylosing Spondylitis

NCT ID: NCT00858819

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-12-31

Brief Summary

This is an observational study aiming to study the prevalence and risk factors for osteoporosis and vertebral fractures in patients with ankylosing spondylitis attending three Rheumatology clinics in Western Sweden.

Detailed Description

Background Ankylosing spondylitis (AS) is a common inflammatory rheumatic disease with a prevalence of 0.5-1.0%. Men are more commonly affected by the disease as compared to women, ratio 2.6-4:1. Pain in the back is a frequent symptom of debut. This pain is often associated with sacroilitis. In later stages also the lumbar, thoracic and cervical spine are hit by the disease. Peripheral joints, eyes, heart, lungs and urinary tract may also be influenced.

Osteoporosis in AS In AS the risk of osteoporosis is increased. However, this field has not yet been significantly studied probably due to several reasons such as the predominance of men with the disease and men are more seldom investigated for osteoporosis compared to women. When AS progresses syndesmophytes of the spine are developed which makes it difficult to assess bone mineral density (BMD) correctly with the conventional method, dual energy x-ray absorptiometry (DXA). Fractures in the spine are easy to foreseen since the pain of the patient might be misjudged to be related to increased disease activity. Fractures are also overlooked in radiographs in AS. AS is associated with both increased bone formation and increased bone resorption. The bone remodeling process in the spine renders the spine less flexible and stiffer and as a consequence also a quite small trauma may result in a fracture. These fractures are often instable risking injuring the spinal cord and nerves.

Aims of the study

• To investigate the prevalence of osteoporosis and osteoporosis related fractures in patients with AS in Western Sweden.
• To identify risk factors for osteoporosis and osteoporosis related fractures in AS.
• To study how fractures in the spine may influence the pain in the back, the flexibility of the spine and the posture of the patients.
• To study to which extent the patients with AS are investigated and treated for osteoporosis.
• To investigate which method is most reliable for measuring BMD in AS.

Design and methods This is an observational study consisting of questionnaires, examination of the patients, blood tests, measures of BMD with different techniques, DXA, both frontal-dorsal and lateral projections, Quantitative Computed Tomography (QCT) and Xtreme CT. Patients with AS from three rheumatology clinics in western Sweden with definite AS will be invited to participate. It is estimated that about 250 patients will be included in the trial. All patients gave informed written consent according to the Declaration of Helsinki. The study has been approved by the Regional Ethics Committee.

Conditions

Ankylosing Spondylitis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

AS

Patients with AS attending three different rheumatology clinics in Western Sweden have been invited to participate.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Definitive Ankylosing spondylitis according to the New York criteria
• At least 18 years old

Exclusion Criteria

• Pregnant
• Dementia
• Not able to understand, speak or read Swedish

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helena Forsblad d'Elia, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology and Inflammation Research

Locations

Department of Rheumatology and Inflammation Research

Gothenburg, , Sweden

Countries

Sweden

References

Klingberg E, Magnusson MK, Strid H, Deminger A, Stahl A, Sundin J, Simren M, Carlsten H, Ohman L, Forsblad-d'Elia H. A distinct gut microbiota composition in patients with ankylosing spondylitis is associated with increased levels of fecal calprotectin. Arthritis Res Ther. 2019 Nov 27;21(1):248. doi: 10.1186/s13075-019-2018-4.

Reference Type: DERIVED

PMID: 31771630 (View on PubMed)

Law L, Beckman Rehnman J, Deminger A, Klingberg E, Jacobsson LTH, Forsblad-d'Elia H. Factors related to health-related quality of life in ankylosing spondylitis, overall and stratified by sex. Arthritis Res Ther. 2018 Dec 27;20(1):284. doi: 10.1186/s13075-018-1784-8.

Reference Type: DERIVED

PMID: 30587228 (View on PubMed)

Torres L, Klingberg E, Nurkkala M, Carlsten H, Forsblad-d'Elia H. Hepatocyte growth factor is a potential biomarker for osteoproliferation and osteoporosis in ankylosing spondylitis. Osteoporos Int. 2019 Feb;30(2):441-449. doi: 10.1007/s00198-018-4721-4. Epub 2018 Oct 10.

Reference Type: DERIVED

PMID: 30306221 (View on PubMed)

Deminger A, Klingberg E, Geijer M, Gothlin J, Hedberg M, Rehnberg E, Carlsten H, Jacobsson LT, Forsblad-d'Elia H. A five-year prospective study of spinal radiographic progression and its predictors in men and women with ankylosing spondylitis. Arthritis Res Ther. 2018 Aug 3;20(1):162. doi: 10.1186/s13075-018-1665-1.

Reference Type: DERIVED

PMID: 30075808 (View on PubMed)

Klingberg E, Strid H, Stahl A, Deminger A, Carlsten H, Ohman L, Forsblad-d'Elia H. A longitudinal study of fecal calprotectin and the development of inflammatory bowel disease in ankylosing spondylitis. Arthritis Res Ther. 2017 Feb 2;19(1):21. doi: 10.1186/s13075-017-1223-2.

Reference Type: DERIVED

PMID: 28148281 (View on PubMed)

Other Identifiers

VGFOUREG11961

Identifier Type: -

Identifier Source: org_study_id