At a glance
ClinicalIndex Comparison Record- ✓Age 30 years or older
- ✓Serum alkaline phosphatase (SAP) at least 2 times the upper limit of normal
- ✓Confirmed diagnosis of Paget's disease of the bone by imaging (x-ray, MRI, CT, or radioisotope imaging)
- ✕Allergic reaction to bisphosphonates
- ✕History of upper gastrointestinal disorders
- ✕History of iritis or uveitis
- ✕Calculated creatinine clearance less than 30 mL/min at baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observation Period
In Brief
A Phase 3 clinical trial evaluating zoledronic acid, placebo to zoledronic acid, and 3 other interventions for Paget's Disease of Bone. Completed, enrolled 185 participants across 41 sites in 10 countries.
Detailed Summary
The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.
Study Details
Timeline
Interventions
5 mg zoledronic acid in 5 mL of sterile water for infusion
5 mL of sterile water for infusion
30mg oral tablets overencapsulated to match the placebo capsules
oral capsules
Calcium and vitamin D supplements were supplied