Ankylosing SpondylitisNCT00858819
Clinical Trial of Osteoporosis in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2009to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with definitive ankylosing spondylitis attending three rheumatology clinics in Western Sweden.
Who may be able to join
- Definitive Ankylosing spondylitis according to the New York criteria
- At least 18 years old
Who cannot join
- Pregnant
- Dementia
- Not able to understand, speak or read Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Rheumatology and Inflammation Research
Gothenburg, S-41346
About this study
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.
Read the 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
- Keywords
- Osteoporosis, Fractures, Bone Mineral Density, Quantitative Computed Tomography
- Medical subject headings
- Spondylitis, Ankylosing, Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AS | Patients with AS attending three different rheumatology clinics in Western Sweden have been invited to participate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of osteoporosis and osteoporosis related fractures in patients with AS in Western Sweden.
Measured: October 2009
Secondary outcomes (1)
To investigate which method is the most reliable for measuring bone mineral density in ankylosing spondylitis
Measured: May 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Forsblad d'Elia, Md, PhD, Principal investigator, Department of Rheumatology and Inflammation Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858819
- Sponsor's protocol ID
- VGFOUREG11961
- Status last verified
- May 2015
- First submitted
- 9 Mar 2009
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31771630Law 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.
PubMed 30587228Torres 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.
PubMed 30306221Deminger 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.
PubMed 30075808Klingberg 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.
PubMed 28148281
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Osteoporosis in Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00858819
- Acronym / sponsor ID
- VGFOUREG11961
- Conditions
- Ankylosing Spondylitis
- Keywords
- Osteoporosis, Fractures, Bone Mineral Density, Quantitative Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AS | – | –Patients with AS attending three different rheumatology clinics in Western Sweden have been invited to participate. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with definitive ankylosing spondylitis attending three rheumatology clinics in Western Sweden.
Key inclusion criteria (2 listed)
- Definitive Ankylosing spondylitis according to the New York criteria
- At least 18 years old
Key exclusion criteria (3 listed)
- Pregnant
- Dementia
- Not able to understand, speak or read Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of osteoporosis and osteoporosis related fractures in patients with AS in Western Sweden.
Time frame: October 2009
1 secondary outcome
To investigate which method is the most reliable for measuring bone mineral density in ankylosing spondylitis
Time frame: May 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Derived from this study: PubMed 31771630Klingberg 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.
- Derived from this study: PubMed 30587228Law 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.
- Derived from this study: PubMed 30306221Torres 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.
- Derived from this study: PubMed 30075808Deminger 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.
- Derived from this study: PubMed 28148281Klingberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Forsblad d'Elia, Md, PhD principal investigator
Department of Rheumatology and Inflammation Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of osteoporosis and osteoporosis related fractures in patients with AS in Western Sweden. (time frame: October 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858819, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.