A multinational, multicenter, randomized, double-blind,double-dummy, stratified, active controlled parallel groupstudy comparing the efficacy and safety of intravenouszoledronic acid, 5 mg once yearly, and oral risedronate, 5mg daily, in the prevention and treatment of corticosteroidinduced osteoporosis - 2306

• Conditions: corticosteroid induced osteoporosis

• Registration Number: EUCTR2004-000248-25-HU
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

(for full list see protocol):
• Male and female patients 18 to 85 years age old
• Patients treated with at least 7.5 mg of oral prednisone per day (or equivalent systemic corticosteroid) and expected to continue corticosteroids therapy for at least a 12 month period:
Treated for less or equal to 3 months prior to study entry (prevention sub-population)
Treated for more than 3 months prior to study entry (treatment sub-population).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(for full list see protocol):
• Any prior use of bisphosphonate preparations except according to the washout schedule at
time of randomization:
2 years (if use >48 weeks)
1 year (if used >8 weeks but <48 weeks)
6 months (if used >2 weeks but <8 weeks)
2 months (if used <2 weeks)
• Any prior use of i.v. bisphosphonate within 2 years prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified