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

INTERVENTION: Trade Name: Aclasta Pharmaceutical Form: Intravenous infusion CONDITION: Ankylosing Spondylitis ; MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis PRIMARY OUTCOME: Main Objective: To evaluate whether Aclasta (5mg iv) is likely to have a therapeutic effect on the inflammatory lesions of Ankylosing Spondylitis (AS) assessed by axial skeletal Magnetic Resonance (MR) scanning 6 months after treatment Primary end point(s): Endpoint SPARCC (6‐dvu) score of spine based on MR scan of axial skeleton 6 months after treatment. Secondary Objective: To evaluate any changes in validated clinical indices 3 and 6 months after Aclasta treatment; to evaluate any therapeutic effect of Aclasta on the inflammatory lesions of AS assessed by MR 3 months after treatment; to evaluate change in spinal bone density 12 months after Aclasta treatment assessed by Dual X‐Ray Absorptiometry scanning. 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