Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)

Completed

• Conditions: Ankylosing Spondylitis; Osteoporosis
• Interventions: Drug: alendronate

• Registration Number: NCT01104987
• Lead Sponsor: Göteborg University

Brief 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 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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Fulfill diagnostic criteria of ankylosing spondylitis, 1984 New York
2. Patients should previously have been included in the observational trial, "Clinical study of osteoporosis in ankylosing spondylitis".
3. Patients should not have changed treatment with any biologics the past 4 months.
4. Patients on glucocorticosteroids should not have changed the dose the last 4 months.
5. BMD with a T-score ≤ -2,5 SD assessed by DXA in lumbar spine and/or hip (total hip and/or neck).
6. 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.
7. 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

Exclusion criteria:

1. Ongoing treatment with any bisphosphonate.
2. Ongoing treatment with any sex-hormone.
3. Renal insufficiency, creatinine clearance < 35 ml/min
4. Difficulties in swallowing and/or acute illness in the upper gastro-intestinal canal.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
alendronate	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.

Primary Outcome Measures

Name	Time	Method
Bone mineral density	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.

Secondary Outcome Measures

Name	Time	Method
Markers of bone remodeling	2 years	To investigate the effects on serum markers of bone remodeling by treatment with alendronate.
Disease activity	2 years	To investigate if alendronate influences disease activity measured by the validated instrument BASDAI.
Spinal function	2 years	To investigate if alendronate influences spinal function measured by the validated instrument BASFI.
Spinal movement	2 years	To investigate if alendronate influences spinal movement measured by the validated instrument BASMI.
Health related quality of life	2 years	To investigate if alendronate influences health related quality of life measured by the validated instrument SF-36.

Trial Locations

Locations (1)

Department of Rheumatology, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden