Clinical trial NCT00858819: Clinical Trial of Osteoporosis in Ankylosing Spondylitis
Official title: Clinical Trial of Osteoporosis in Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Osteoporosis
Fractures
Bone Mineral Density
Quantitative Computed Tomography
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with definitive ankylosing spondylitis attending three rheumatology clinics in Western Sweden.

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.

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

Primary outcomes:
measure: The prevalence of osteoporosis and osteoporosis related fractures in patients with AS in Western Sweden.
timeFrame: October 2009
Secondary outcomes:
measure: To investigate which method is the most reliable for measuring bone mineral density in ankylosing spondylitis
timeFrame: May 2010
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Rheumatology and Inflammation Research
Study officials:
affiliation: Department of Rheumatology and Inflammation Research
name: Helena Forsblad d'Elia, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.