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| Sponsored by: |
Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00103740 |
Purpose
The primary objective of this study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response.
| Condition | Intervention | Phase |
|---|---|---|
|
Paget's Disease of Bone |
Drug: zoledronic acid and placebo Drug: risedronate and placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized, Double-Blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator |
| Estimated Enrollment: | 176 |
| Study Start Date: | April 2002 |
| Estimated Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator | Drug: zoledronic acid and placebo |
| 2: Active Comparator | Drug: risedronate and placebo |
Efficacy: The primary efficacy variable was the proportion of patients who achieved therapeutic response. A therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP.
Safety: Safety assessments consisted of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry, serum PTH, and urinalysis, regular measurement of vital signs and the performance of physical examinations. Special safety evaluations included bone biopsies, and the assessment of renal abnormalities.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations More Information
| Responsible Party: | Novartis ( External Affairs ) |
| Study ID Numbers: | CZOL446H_2305 |
| Study First Received: | February 14, 2005 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00103740 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Zoledronic acid, risedronate, Paget's disease of bone |
|
Calcium, Dietary Diphosphonates Zoledronic acid Musculoskeletal Diseases Osteitis Deformans Calcium Channel Blockers |
Bone Density Conservation Agents Paget Disease Cardiovascular Agents Osteitis Bone Diseases Risedronic acid |
|
Zoledronic acid Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Blockers Bone Density Conservation Agents Cardiovascular Agents Bone Diseases |
Pharmacologic Actions Membrane Transport Modulators Diphosphonates Musculoskeletal Diseases Therapeutic Uses Osteitis Deformans Risedronic acid |
