drugset / Trial / NCT00051636
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2001-01
- Primary completion
- 2004-03
- Completion
- 2011-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Risedronate | Small molecule | 30 mg | Oral |
| Subject | Zoledronic acid | Other / unclassified | 5 mg | Intravenous |