Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu
Trial record 1 of 1 for:    NCT00858819
Previous Study | Return to List | Next Study

Clinical Trial of Osteoporosis in Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00858819
Recruitment Status : Completed
First Posted : March 10, 2009
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
Göteborg University

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.

Layout table for study information
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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.

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

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 identifier (NCT number): NCT00858819

Layout table for location information
Department of Rheumatology and Inflammation Research
Gothenburg, Sweden, S-41346
Sponsors and Collaborators
Göteborg University
Layout table for investigator information
Principal Investigator: Helena Forsblad d'Elia, Md, PhD Department of Rheumatology and Inflammation Research
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Göteborg University Identifier: NCT00858819    
Other Study ID Numbers: VGFOUREG11961
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Keywords provided by Göteborg University:
Bone Mineral Density
Quantitative Computed Tomography
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis, Ankylosing
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Diseases, Infectious
Spinal Diseases
Joint Diseases
Axial Spondyloarthritis