Clinical Trial of Osteoporosis in Ankylosing Spondylitis

• ClinicalTrials.gov Identifier: NCT00858819
• Recruitment Status: Completed
• First Posted: March 10, 2009
• Last Update Posted: May 29, 2015
• Sponsor: Göteborg University
• Information provided by (Responsible Party): Göteborg University

Study Description

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.

Condition or disease
Ankylosing Spondylitis

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 250 participants
• Observational Model: Case-Crossover
• Time Perspective: Cross-Sectional
• Official Title: Clinical Trial of Osteoporosis in Ankylosing Spondylitis
• Study Start Date: March 2009
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: December 2014

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. The prevalence of osteoporosis and osteoporosis related fractures in patients with AS in Western Sweden. [ Time Frame: October 2009 ]

Secondary Outcome Measures :

1. To investigate which method is the most reliable for measuring bone mineral density in ankylosing spondylitis [ Time Frame: May 2010 ]

Biospecimen Retention:   Samples Without DNA

Serum

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients with definitive ankylosing spondylitis attending three rheumatology clinics in Western Sweden.

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

Contacts and Locations

Locations

Sweden

Department of Rheumatology and Inflammation Research

Gothenburg, Sweden, S-41346

Sponsors and Collaborators

Göteborg University

Investigators

• Principal Investigator: Helena Forsblad d'Elia, Md, PhD; Department of Rheumatology and Inflammation Research

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

• Responsible Party: Göteborg University
• ClinicalTrials.gov Identifier: NCT00858819
• Other Study ID Numbers: VGFOUREG11961
• First Posted: March 10, 2009
• Last Update Posted: May 29, 2015
• Last Verified: May 2015

Keywords provided by Göteborg University:

Osteoporosis; Fractures; Bone Mineral Density; Quantitative Computed Tomography

Additional relevant MeSH terms:

Spondylitis; Osteoporosis; Spondylarthritis; Spondylitis, Ankylosing; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Infectious; Infections; Spinal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Spondylarthropathies; Ankylosis