An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07

• Conditions: Ankylosing Spondylitis; MedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis

• Registration Number: EUCTR2007-000087-25-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

To be included in the study the patient must have Ankylosing Spondylitis, be >18y old, have a BASDAI (composite clinical disease activity score) =4.15, be able to have a spinal MR and have one or more lesions on axial MR characteristic of inflammatory lesions of AS.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients <18y, prisoners, complete spinal ankylosis, those unable to give written consent themselves, renal dysfunction (Chronic Kidney Disease grade 4 or 5 by MDRD GFR estimation <30ml/min [e-GFR]), previous anti-TNFalpha therapy in last year, previous reaction to zoledronate, patients with obvious poor dentition/oral health, or those who have recently had root dental work or root/extraction dental work planned within the study period.

Also to be excluded: All women of child-bearing potential; pregnant women and those breast-feeding; all those unable to give written consent themselves

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified