Clinical Trial of Osteoporosis in Ankylosing Spondylitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT00858819
First received: March 9, 2009
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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
Ankylosing Spondylitis

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Clinical Trial of Osteoporosis in Ankylosing Spondylitis

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • The prevalence of osteoporosis and osteoporosis related fractures in patients with AS in Western Sweden. [ Time Frame: October 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate which method is the most reliable for measuring bone mineral density in ankylosing spondylitis [ Time Frame: May 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 250
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
AS
Patients with AS attending three different rheumatology clinics in Western Sweden have been invited to participate.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858819

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

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT00858819     History of Changes
Other Study ID Numbers: VGFOUREG11961
Study First Received: March 9, 2009
Last Updated: June 25, 2014
Health Authority: Sweden: Institutional Review Board

Keywords provided by Göteborg University:
Osteoporosis
Fractures
Bone Mineral Density
Quantitative Computed Tomography

Additional relevant MeSH terms:
Osteoporosis
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Infection
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on September 18, 2014