Condition category
Musculoskeletal Diseases
Date applied
04/05/2005
Date assigned
23/05/2005
Last edited
03/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.arc.org.uk/research/grantdet.asp?Code=B0735

Contact information

Type

Scientific

Primary contact

Dr Ashok Bhalla

ORCID ID

Contact details

Dept of Rheumatology
Royal National Hospital for Rheumatic Diseases
Upper Borough Walls
Bath
BA1 1RL
United Kingdom
+44 (0)1225 473443

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14585

Study information

Scientific title

Acronym

BIAS

Study hypothesis

The bisphosphonates will not alter clinical outcome in ankylosing spondylitis

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Ankylosing Spondylitis (AS)

Intervention

Placebo or Alendronate 70 mg weekly

Intervention type

Drug

Phase

Not Specified

Drug names

alendronate

Primary outcome measures

BAS-G

Secondary outcome measures

BASDAI, BASFI and BASRI, ESR, CRP, use of NSAIDs, bone density and vertebral deformity.

Overall trial start date

01/08/2004

Overall trial end date

31/08/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

180

Participant 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

Recruitment start date

01/08/2004

Recruitment end date

31/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Rheumatology
Bath
BA1 1RL
United Kingdom

Sponsor information

Organisation

Royal National Hospital for Rheumatic Diseases (UK)

Sponsor details

Upper Borough Walls
Bath
BA1 1RL
United Kingdom
+44 (0)1225 473440
Nicola.Carmichael@rnhrd-tr.swest.nhs.uk

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign 14585

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes