Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Calcium; Calcium, Dietary; Diphosphonates; Ergocalciferols; Etidronic Acid; Risedronate Sodium; Risedronic Acid; Vitamin D; Vitamins; Zoledronic Acid

Criteria

Inclusion Criteria:

• 30 years or older

• SAP 2 times ULN

• Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.).

• 90 days washout calcitonin

• 180 day washout bisphosphonate

Exclusion Criteria:

• Allergic reaction to bisphosphonates

• History of upper GI disorders

• History of iritis, uveitis

• Calculated creatinine clearance < 30 ml/min at baseline

• Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria may apply.