The effects of bisphosphonates on disease activity and bone status in ankylosing spondylitis (BIAS)
| ISRCTN | ISRCTN87639321 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87639321 |
| Secondary identifying numbers | 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | alendronate |
| Primary outcome measure | BAS-G |
| Secondary outcome measures | BASDAI, BASFI and BASRI, ESR, CRP, use of NSAIDs, bone density and vertebral deformity. |
| Overall study start date | 01/08/2004 |
| Completion date | 31/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Dept of Rheumatology
Bath
BA1 1RL
United Kingdom
BA1 1RL
United Kingdom
Sponsor information
Royal National Hospital for Rheumatic Diseases (UK)
Not defined
Not defined
Upper Borough Walls
Bath
BA1 1RL
United Kingdom
| Phone | +44 (0)1225 473440 |
|---|---|
| Nicola.Carmichael@rnhrd-tr.swest.nhs.uk | |
"ROR" |
https://ror.org/05va5gy74 |
Funders
Funder type
Charity
Arthritis Research Campaign 14585
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
