The effects of bisphosphonates on disease activity and bone status in ankylosing spondylitis (BIAS)
| ISRCTN | ISRCTN87639321 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87639321 |
| Protocol serial number | 14585 |
| Sponsor | Royal National Hospital for Rheumatic Diseases (UK) |
| Funder | Arthritis Research Campaign 14585 |
- Submission date
- 04/05/2005
- Registration date
- 23/05/2005
- Last edited
- 03/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ashok Bhalla
Scientific
Scientific
Dept of Rheumatology
Royal National Hospital for Rheumatic Diseases
Upper Borough Walls
Bath
BA1 1RL
United Kingdom
| Phone | +44 (0)1225 473443 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | BIAS |
| Study objectives | The bisphosphonates will not alter clinical outcome in ankylosing spondylitis |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ankylosing Spondylitis (AS) |
| Intervention | Placebo or Alendronate 70 mg weekly |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | alendronate |
| Primary outcome measure(s) |
BAS-G |
| Key secondary outcome measure(s) |
BASDAI, BASFI and BASRI, ESR, CRP, use of NSAIDs, bone density and vertebral deformity. |
| Completion date | 31/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 180 |
| Key inclusion criteria | Age > 21, stable dose of non-steroidal anti-inflammatory drug (NSAID) for last four weeks. Need to fulfil New York Criteria for AS. |
| Key exclusion criteria | 1. Systemic steroids for the last three months 2. Bisphosphonates in the last 12 months 3. Oesophageal disease or active peptic ulcer 4. Unable to give informed consent 5. Known Paget's Disease 6. Renal disease with creatinine >150 mmol/l, hypercalcaemia, osteomalacia, inflammatory bowel disease, known malignancy and reduced life expectancy <2 years |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 31/08/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Dept of Rheumatology
Bath
BA1 1RL
United Kingdom
BA1 1RL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
