Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
NCT ID: NCT00103740
Last Updated: 2012-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
185 participants
INTERVENTIONAL
2002-04-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Zoledronic acid and placebo to risedronate
Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
zoledronic acid
5 mg zoledronic acid in 5 mL of sterile water for infusion
Placebo to risedronate
oral capsules
Calcium and vitamin D supplements
Calcium and vitamin D supplements were supplied
Risedronate and placebo to zoledronic acid
Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
placebo to zoledronic acid
5 mL of sterile water for infusion
Risedronate
30mg oral tablets overencapsulated to match the placebo capsules
Calcium and vitamin D supplements
Calcium and vitamin D supplements were supplied
Interventions
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zoledronic acid
5 mg zoledronic acid in 5 mL of sterile water for infusion
placebo to zoledronic acid
5 mL of sterile water for infusion
Risedronate
30mg oral tablets overencapsulated to match the placebo capsules
Placebo to risedronate
oral capsules
Calcium and vitamin D supplements
Calcium and vitamin D supplements were supplied
Eligibility Criteria
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Inclusion Criteria
* 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
* History of upper GI disorders
* History of iritis, uveitis
* Calculated creatinine clearance \< 30 ml/min at baseline
* Evidence of vitamin D deficiency
30 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Leverkusen, , Germany
Novartis Investigative Site
Wirzburg, , Germany
Novartis Investigative site
Christchurch, , New Zealand
Novartis Investigative site
Cape Town, , South Africa
Novartis Investigative site
Barcelona, , Spain
Novartis Investigative site
Madrid, , Spain
Novartis Investigative Site
Málaga, , Spain
Novartis Investigative Site
Salamanca, , Spain
Novartis Investigative site
Santiago de Compostela, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigative Site
Liverpool, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative site
Oxford, , United Kingdom
Countries
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Other Identifiers
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ZOL446K2305
Identifier Type: OTHER
Identifier Source: secondary_id
CZOL446H2305
Identifier Type: -
Identifier Source: org_study_id
NCT00051649
Identifier Type: -
Identifier Source: nct_alias
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