Alendronate in ankylosing spondylitis trial

Phase 1

Completed

Conditions: Ankylosing spondylitis
Musculoskeletal Diseases

Registration Number: ISRCTN12308164

Lead Sponsor: Royal National Hospital for Rheumatic Diseases (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 180

Inclusion Criteria

1. Patients had to meet the modified New York criteria for the diagnosis of AS, which we refined to allow for MRI diagnosis of sacroiliitis, and a requirement for a minimum pre-defined movement restriction
2. Fulfil ASAS criteria for axial SpA
3. Aged over 21 years
4. If taking NSAID, have been on a stable dose for at least 4 weeks
5. There was no minimal level of disease activity required for entry to the study

Exclusion Criteria

1. Any intervention or underlying disease with the potential to effect disease activity or bone density, including treatment with anti-TNF
2. Patients with bilateral hip replacements or previous back surgery that would prevent accurate bone density measurement by dual x-ray absorptiometry (DXA)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bath Ankylosing Spondylitis Global score (BAS-G), assessing overall change in patient’s symptoms and general health over the preceding month. Scored at baseline, 3, 6, 12, 18 and 24 months

Secondary Outcome Measures

Name	Time	Method
1. Disease activity (Bath AS Disease Activity Index (BASDAI) scored at baseline, 3, 6, 12, 18 and 24 months <br>2. Physical function (Bath AS Functional Index (BASFI) scored at baseline, 3, 6, 12, 18 and 24 months <br>3. Mobility (Bath AS Metrology Index (BASMI) measured at baseline and 24 months<br>4. Laboratory measurements:<br>4.1. At baseline and 6 months blood was taken for measurement of cytokines and metalloproteinases <br>4.2. The inflammation marker, CRP, was measured at baseline, 3, 6, 12 and 24 months<br>5. Radiographic features were assessed by modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) and Bath AS Radiology Index (BASRI) at 0 and 24 months<br>6. Assessment in SpondyloArthritis international Society (ASAS) 20 and ASAS40 at 0 and 24 months