At a glance
ClinicalIndex Comparison Record- ✓Age 30 years or older
- ✓Serum alkaline phosphatase at least 2 times the upper limit of normal
- ✓Confirmed diagnosis of Paget's disease of bone by imaging (x-ray, MRI, CT, or radioisotope imaging)
- ✓90-day washout from calcitonin therapy
- ✕Known 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 Observational Period
In Brief
A Phase 3 clinical trial evaluating Zoledronic Acid, Risedronate, and 3 other interventions for Paget's Disease of Bone. Completed, enrolled 172 participants across 34 sites in 6 countries.
Detailed Summary
The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.
Study Details
Timeline
Interventions
Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.
Oral risedronate 30 mg capsules.
Oral placebo of risedronate capsules.
5 mL of sterile water one dose intravenous infusion.
Calcium and vitamin D supplements were supplied.