Ankylosing SpondylitisNCT01104987
Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)
An observational study of Ankylosing Spondylitis and Osteoporosis, run by Göteborg University at 1 site in Sweden.
Trial summary
This prospective study will assess the effects of treatment with alendronate in osteoporotic patients with ankylosing spondylitis. Primary objectives: To investigate if alendronate effect bone mineral density (BMD) assessed by dual energy x-ray absorptiometry (DXA) in lumbar spine, hip and distal forearm and assessed… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankylosing Spondylitis, Osteoporosis
- What is being tested?
- alendronate
- Type of treatment
- Pill or oral medicine
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Jul 2016
- 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 AS and osteoporosis.
Who may be able to join
- Fulfill diagnostic criteria of ankylosing spondylitis, 1984 New York
- Patients should previously have been included in the observational trial, "Clinical study of osteoporosis in ankylosing spondylitis".
- Patients should not have changed treatment with any biologics the past 4 months.
- Patients on glucocorticosteroids should not have changed the dose the last 4 months.
- BMD with a T-score ≤ -2,5 SD assessed by DXA in lumbar spine and/or hip (total hip and/or neck).
- BMD with a T-score ≤ -2,0 SD assessed by DXA in lumbar spine and/or hip (total hip and/or neck) and presence of any vertebral fracture, hip fracture or peripheral fragility fracture.
- BMD with a T-score ≤ - 1,0 SD assessed by DXA in lumbar spine and/or hip (total hip and/or neck) in patients on oral glucocorticosteroids
Who cannot join
- Ongoing treatment with any bisphosphonate.
- Ongoing treatment with any sex-hormone.
- Renal insufficiency, creatinine clearance < 35 ml/min
- Difficulties in swallowing and/or acute illness in the upper gastro-intestinal canal.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Rheumatology, Sahlgrenska University Hospital
Gothenburg, S-413 45
About this study
Official title: Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective Trial
This prospective study will assess the effects of treatment with alendronate in osteoporotic patients with ankylosing spondylitis.
Primary objectives:
- To investigate if alendronate effect bone mineral density (BMD) assessed by dual energy x-ray absorptiometry (DXA) in lumbar spine, hip and distal forearm and assessed by quantitative computed tomography (QCT) in lumbar spine and by Xtreme CT in radius and tibia.
Secondary objectives:
- To investigate if alendronate effects markers of bone remodeling
- To investigate if alendronate influences disease activity (BASDAI), spinal function (BASFI), spinal movement (BASMI) and health related quality of life (SF-36).
Read the detailed description
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.
The risk of osteoporosis is increased in AS. 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.
Treatment with bisphosphonates in AS have indicated an anti-inflammatory effect. The effects of treatment with bisphosphonate on BMD assessed by DXA, QCT and Xtreme CT in AS has not yet been fully investigated.
- Conditions
- Ankylosing Spondylitis, Osteoporosis
- Being tested
- alendronate
- Keywords
- Ankylosing spondylitis, spondarthritis, Osteoporosis, Bone mineral density, Dual energy x-ray absorptiometry, Quantitative computed tomography
- Medical subject headings
- Spondylitis, Ankylosing, Osteoporosis, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronateDrug
One tablet of alendronate à 70 mg once a week during two years.
| Study group | Role | What they receive |
|---|---|---|
| alendronate | A cross sectional study assessing the prevalence of osteoporosis and vertebral fractures in AS has been conducted during the spring in 2009. Patients with osteoporosis that fulfilled the inclusion criteria and did not have any exclusion criteria for the present trial were asked to join this study. Receives: Drug: alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
The effect on bone mineral density (BMD) assessed by dual energy x-ray absorptiometry (DXA) in lumbar spine, hip and distal forearm and assessed by quantitative computed tomography (QCT) in lumbar spine and by Xtreme CT in radius and tibia by treatment with alendronate.
Measured: 2 years
Secondary outcomes (5)
Markers of bone remodeling
To investigate the effects on serum markers of bone remodeling by treatment with alendronate.
Measured: 2 years
Disease activity
To investigate if alendronate influences disease activity measured by the validated instrument BASDAI.
Measured: 2 years
Spinal function
To investigate if alendronate influences spinal function measured by the validated instrument BASFI.
Measured: 2 years
Spinal movement
To investigate if alendronate influences spinal movement measured by the validated instrument BASMI.
Measured: 2 years
Health related quality of life
To investigate if alendronate influences health related quality of life measured by the validated instrument SF-36.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
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, Sahlgrenska Academy at University of Gothenburg, Department of Rheumatology and Inflammation Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104987
- Sponsor's protocol ID
- 20090618
- Status last verified
- Aug 2016
- First submitted
- 13 Apr 2010
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective Trial
- ClinicalTrials.gov ID
- NCT01104987
- Acronym / sponsor ID
- 20090618
- Conditions
- Ankylosing Spondylitis, Osteoporosis
- Keywords
- Ankylosing spondylitis, spondarthritis, Osteoporosis, Bone mineral density, Dual energy x-ray absorptiometry, Quantitative computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Apr 2010 (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 prospective study will assess the effects of treatment with alendronate in osteoporotic patients with ankylosing spondylitis.
Primary objectives:
- To investigate if alendronate effect bone mineral density (BMD) assessed by dual energy x-ray absorptiometry (DXA) in lumbar spine, hip and distal forearm and assessed by quantitative computed tomography (QCT) in lumbar spine and by Xtreme CT in radius and tibia.
Secondary objectives:
- To investigate if alendronate effects markers of bone remodeling
- To investigate if alendronate influences disease activity (BASDAI), spinal function (BASFI), spinal movement (BASMI) and health related quality of life (SF-36).
Detailed description
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.
The risk of osteoporosis is increased in AS. 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.
Treatment with bisphosphonates in AS have indicated an anti-inflammatory effect. The effects of treatment with bisphosphonate on BMD assessed by DXA, QCT and Xtreme CT in AS has not yet been fully investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alendronate | – | Drug: alendronateA cross sectional study assessing the prevalence of osteoporosis and vertebral fractures in AS has been conducted during the spring in 2009. Patients with osteoporosis that fulfilled the inclusion criteria and did not have any exclusion criteria for the present trial were asked to join this study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AS and osteoporosis.
Key inclusion criteria (7 listed)
- Fulfill diagnostic criteria of ankylosing spondylitis, 1984 New York
- Patients should previously have been included in the observational trial, "Clinical study of osteoporosis in ankylosing spondylitis".
- Patients should not have changed treatment with any biologics the past 4 months.
- Patients on glucocorticosteroids should not have changed the dose the last 4 months.
- BMD with a T-score ≤ -2,5 SD assessed by DXA in lumbar spine and/or hip (total hip and/or neck).
Key exclusion criteria (4 listed)
- Ongoing treatment with any bisphosphonate.
- Ongoing treatment with any sex-hormone.
- Renal insufficiency, creatinine clearance < 35 ml/min
- Difficulties in swallowing and/or acute illness in the upper gastro-intestinal canal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alendronateOne tablet of alendronate à 70 mg once a week during two years. | Drug | alendronate |
Primary outcome
Bone mineral density
Time frame: 2 years
The effect on bone mineral density (BMD) assessed by dual energy x-ray absorptiometry (DXA) in lumbar spine, hip and distal forearm and assessed by quantitative computed tomography (QCT) in lumbar spine and by Xtreme CT in radius and tibia by treatment with alendronate.
5 secondary outcomes
Markers of bone remodeling
Time frame: 2 years
Disease activity
Time frame: 2 years
Spinal function
Time frame: 2 years
Spinal movement
Time frame: 2 years
Health related quality of life
Time frame: 2 years
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 9 Aug 2016.
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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
Sahlgrenska Academy at University of Gothenburg, 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 and Osteoporosis, 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 7 inclusion and 4 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 9 Aug 2016. 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?
Bone mineral density (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2016.