drugset / Trial / NCT00103740
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 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.
Timeline
- Start
- 2002-04
- Primary completion
- 2003-12
- Completion
- 2011-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Risedronate | Small molecule | 30 mg | Oral |
| Subject | Zoledronic acid | Other / unclassified | 5 mg | Intravenous |
| Background | Calcium carbonate | Other / unclassified | 500 mg | — |
| Background | Vitamin D | Other / unclassified | 400 iu | — |
| Background | Vitamin D | Other / unclassified | 1000 iu | — |