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

Primary Purpose

Ankylosing Spondylitis

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

drug treatment

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

BASDAI

Secondary Outcome Measures

Full Information

NCT ID

NCT01038011

First Posted

December 15, 2009

Last Updated

May 3, 2017

Sponsor

University of Zurich

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01038011

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Zurich

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankylosing Spondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

drug treatment

Primary Outcome Measure Information:

Title

BASDAI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

01 Studienregister MasterAdmins

Organizational Affiliation

UniversitaetsSpital Zuerich

Official's Role

Study Director

Facility Information:

City

Zurich

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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