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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01038011
• Date of registration: 15/12/2009
• Prospective Registration: No
• Primary sponsor: University of Zurich
• Public title: Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot Study
• Date of first enrolment: June 2004
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01038011
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
• Phase: Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: 01 Studienregister MasterAdmins
• Affiliation: UniversitaetsSpital Zuerich

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: drug treatment

Primary Outcome(s)

BASDAI

Secondary ID(s)

Acto_2003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi