Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)
|ClinicalTrials.gov Identifier: NCT01104987|
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : August 9, 2016
This prospective study will assess the effects of treatment with alendronate in osteoporotic patients with ankylosing spondylitis.
- 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.
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Ankylosing Spondylitis Osteoporosis||Drug: alendronate||Phase 4|
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 Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective Trial|
|Study Start Date :||October 2009|
|Primary Completion Date :||July 2016|
|Study Completion Date :||July 2016|
U.S. FDA Resources
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.
One tablet of alendronate à 70 mg once a week during two years.
- 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.
- Markers of bone remodeling [ Time Frame: 2 years ]To investigate the effects on serum markers of bone remodeling by treatment with alendronate.
- Disease activity [ Time Frame: 2 years ]To investigate if alendronate influences disease activity measured by the validated instrument BASDAI.
- Spinal function [ Time Frame: 2 years ]To investigate if alendronate influences spinal function measured by the validated instrument BASFI.
- Spinal movement [ Time Frame: 2 years ]To investigate if alendronate influences spinal movement measured by the validated instrument BASMI.
- Health related quality of life [ Time Frame: 2 years ]To investigate if alendronate influences health related quality of life measured by the validated instrument SF-36.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104987
|Department of Rheumatology, Sahlgrenska University Hospital|
|Gothenburg, Sweden, S-413 45|
|Principal Investigator:||Helena Forsblad d'Elia, MD, PhD||Sahlgrenska Academy at University of Gothenburg, Department of Rheumatology and Inflammation Research|