Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot Study (NCT01038011)

Study summary

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

Conditions studied

Ankylosing Spondylitis

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In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

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Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion criteria: •Male or non-pregnant women (only women who are post menopausal, surgically sterile or practicing a reliable method of contraception may be included) aged 20 years or more

Meeting the Modified New York diagnostic criteria for AS (Van der Linden S et al., 1984)
Symptoms of active AS for more than 6 months prior to study entry
Treated by first-line therapy (NSAIDs) for more than 6 months prior to study entry
Bath AS Disease Activity Index (BASDAI) score of 4 or greater (Garrett S et al, 1994) and
Spinal pain of 4 or greater on a 10-cm visual analogue scale despite maximum recommended or tolerated doses of NSAIDs given for a minimum of 1 month prior to study entry

Exclusion criteria: •End-stage AS with diffuse involvement of the spine (complete ankylosis)

Intraarticular corticosteroid injections or IV infusion with methylprednisolone within the past 2 months prior to study entry. Patients with IA corticosteroid injections of the sacroiliac joints within the past 9 months prior to study entry.
Severe renal insufficiency: serum creatinine > 25% above the upper limit of normal (>177 umol/l)
Hypocalcemia
Major surgery within the past 3 months prior to study entry or planned in the ensuing 12 months
Orthopaedic surgery within the last 12 months
Severe infections or comorbidities, or active peptic ulcer disease
Patients who received bisphosphonates in the past 12 months prior to study entry or patients having known allergies to bisphosphonates.
Patients treated with anti-osteoporotic drugs (except: Calcium and Vit. D) in the past 12 months prior to study entry.
Patients unable to remain in an upright position (sitting or standing) during a minimum of 30 minutes
No written informed consent obtained or inability to collaborate to the study design.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double

Interventions

Drugdrug treatment

What researchers measure

Primary outcomes

BASDAI

Study locations

1 site

Zurich, Switzerland

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01038011
Lead sponsor: University of Zurich
Collaborators: Sanofi
First posted: Dec 23, 2009
Start date: Jun 2004
Completion: Aug 2006
Last update: May 8, 2017

Study contacts

01 Studienregister MasterAdmins

study director · UniversitaetsSpital Zuerich

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot Study