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

Completed · Phase 3 · Has a placebo group

Conditions studied: Paget's Disease of Bone

In brief

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.

Key facts

Study ID

NCT00103740

Run by

Novartis Pharmaceuticals

People needed

185

Starts

2002-04-01

Expected to finish

2011-04-01

Last updated by the study team

2012-06-04

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative site — Tucson, Arizona, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Syracuse, New York, United States
• Novartis Investigative Site — Cleveland, Ohio, United States
• Novartis Investigative Site — Medford, Oregon, United States
• Novartis Investigative Site — Columbia, South Carolina, United States
• Novartis Investigative Site — Madison, Wisconsin, United States
• Novartis Investigative Site — Fitzroy, Australia
• Novartis Investigative Site — Kogarah, Australia
• Novartis Investigative site — Newcastle, Australia
• Novartis Investigative Site — Parkville, Australia
• Novartis Investigative site — St Leonards, Australia
• Novartis Investigative site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Montreal, Canada
• Novartis Investigative Site — Angers, France
• Novartis Investigative Site — Dreux, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Nice, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Rouen, France
• Novartis Investigative Site — Toulouse, France

Full record on ClinicalTrials.gov

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