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ISRCTN
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ISRCTN87639321
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ClinicalTrials.gov identifier
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Public title
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The effects of bisphosphonates on disease activity and bone status in ankylosing spondylitis (BIAS)
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Scientific title
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Acronym
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BIAS
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Serial number at source
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14585
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Study hypothesis
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The bisphosphonates will not alter clinical outcome in ankylosing spondylitis
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ankylosing Spondylitis (AS)
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Participants - inclusion criteria
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Age > 21, stable dose of non-steroidal anti-inflammatory drug (NSAID) for last four weeks. Need to fulfil New York Criteria for AS.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/08/2004
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Anticipated end date
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31/08/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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180
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Interventions
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Placebo or Alendronate 70 mg weekly
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Primary outcome measure(s)
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BAS-G
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Secondary outcome measure(s)
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BASDAI, BASFI and BASRI, ESR, CRP, use of NSAIDs, bone density and vertebral deformity.
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Sources of funding
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Arthritis Research Campaign 14585
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Trial website
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http://www.arc.org.uk/research/grantdet.asp?Code=B0735
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Publications
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Contact name
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Dr
Ashok
Bhalla
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Address
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Dept of Rheumatology
Royal National Hospital for Rheumatic Diseases
Upper Borough Walls
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City/town
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Bath
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Zip/Postcode
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BA1 1RL
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Country
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United Kingdom
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Tel
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+44 (0)1225 473443
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Fax
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+44 (0)1225 473437
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Email
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ashok.bhalla@rnhrd-tr.swest.nhs.uk
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Sponsor
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Royal National Hospital for Rheumatic Diseases (UK)
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Address
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Upper Borough Walls
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City/town
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Bath
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Zip/Postcode
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BA1 1RL
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Country
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United Kingdom
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Tel
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+44 (0)1225 473440
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Fax
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+44 (0)1225 473436
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Email
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Nicola.Carmichael@rnhrd-tr.swest.nhs.uk
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Date applied
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04/05/2005
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Last edited
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14/12/2010
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Date ISRCTN assigned
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23/05/2005
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