Ankylosing Spondylitis Clinical Trial
Randomized, controlled, double-blind, multicenter phase II study comparing risedronate 35mg
(ActonelR 35mg weekly tablet) versus placebo in patients with active ankylosing spondylitis
(AS) treated with standard first and second-line therapies.
Primary efficacy endpoint: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The
time schedule for performing the BASDAI was at screening, upon inclusion (T0), then after 3,
6 and 12 months or at the time of premature withdrawal in case of drop-out.
secondary endpoints:
- Clinical endpoints: The secondary efficacy measures were the following: Bath Ankylosing
Spondylitis Functional Index (BASFI) , Bath Ankylosing Spondylitis Metrology Index
(BASMI), ASAS (Assessments in Ankylosing Spondylitis) Working Group core set of
domains, Spinal pain VAS, ESR, CRP and the percentage of patients achieving 20% or
greater decrease in each of these parameters. These parameters were determined at T0,
T3, T6, T12 or at the time of premature withdrawal in case of drop-out. The spinal pain
assessed by VAS was also done at screening.
- DEXA: Dual Energy X-Ray-Absorptiometry (DEXA) measurements were performed in all
patients upon inclusion (T0) and at the end of the study (T12).
- Biochemical markers: selected biochemical markers of bone metabolism were measured at
T0, T3, T6 and T12 or at the time of premature withdrawal in case of drop-out using
commercially available kits. Bone formation was assessed by serum bone-specific
alkaline phosphatase (BAP) and osteocalcin (OC) levels using commercially available
kits. Bone resorption was assessed in serum by the C-terminal telopeptide of type I
collagen degradation (Crosslaps R) and urinary N-terminal telopeptide of type I
collagen degradation (Osteomark R).
- Trial with medicinal product
n/a
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