Overview

Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)

Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
0
Participant gender:
All
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).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Göteborg University
Treatments:
Alendronate
Criteria
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.