Status:
COMPLETED
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Paget's Disease of Bone
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief 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 obser...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00103740
Start Date
April 1 2002
End Date
April 1 2011
Last Update
June 4 2012
Active Locations (41)
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1
Novartis Investigative site
Tucson, Arizona, United States, 85732
2
Novartis Investigative Site
Colorado Springs, Colorado, United States, 80901
3
Novartis Investigative Site
Indianapolis, Indiana, United States, 46202
4
Novartis Investigative Site
New Orleans, Louisiana, United States, 70121