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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01038011
First received: December 15, 2009
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  Purpose

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

Condition Intervention Phase
Ankylosing Spondylitis
 Drug: drug treatment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • BASDAI

Study Start Date: June 2004
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038011

Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Sanofi
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01038011     History of Changes
Other Study ID Numbers: Acto_2003
Study First Received: December 15, 2009
Last Updated: February 2, 2010
Health Authority: Switzerland: UZurich

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
 Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 16, 2013