Ankylosing SpondylitisPhase 2NCT01038011
Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot Study
A Phase 2 study testing drug treatment in people with Ankylosing Spondylitis, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- drug treatment
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2004to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Ankylosing Spondylitis
- Being tested
- drug treatment
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug treatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
BASDAI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJun 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038011
- Sponsor's protocol ID
- Acto_2003
- Status last verified
- May 2017
- First submitted
- 15 Dec 2009
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot Study
- ClinicalTrials.gov ID
- NCT01038011
- Acronym / sponsor ID
- Acto_2003
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jun 2004
- Study completion
- Aug 2006
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug treatment | Drug | – |
Primary outcome
BASDAI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing drug treatment in people with Ankylosing Spondylitis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BASDAI. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.