Alendronate in ankylosing spondylitis trial

Clinical efficacy of oral alendronate in ankylosing spondylitis: a randomised placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12308164

Enrollment

180

Registered

2015-12-15

Start date

2005-05-01

Completion date

Unknown

Last updated

2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing spondylitis Musculoskeletal Diseases Ankylosing spondylitis

Interventions

Oral alendronate 70 mg weekly or placebo The total duration of treatment was 2 years and follow-up for all treatment arms was 2 years from enrolment.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026