Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
NCT ID: NCT00051636
Last Updated: 2012-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
172 participants
INTERVENTIONAL
2001-01-31
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 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Zoledronic Acid
Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.
Placebo to Risedronate
Oral placebo of risedronate capsules.
Calcium and Vitamin D
Calcium and vitamin D supplements were supplied.
Risedronate and Placebo to Zoledronic Acid
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Risedronate
Oral risedronate 30 mg capsules.
Placebo to Zoledronic Acid
5 mL of sterile water one dose intravenous infusion.
Calcium and Vitamin D
Calcium and vitamin D supplements were supplied.
Interventions
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Zoledronic Acid
Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.
Risedronate
Oral risedronate 30 mg capsules.
Placebo to Risedronate
Oral placebo of risedronate capsules.
Placebo to Zoledronic Acid
5 mL of sterile water one dose intravenous infusion.
Calcium and Vitamin D
Calcium and vitamin D supplements were supplied.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum alkaline phosphatase (SAP) 2 times upper limit normal (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 gastrointestinal 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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Locations
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Novartis Investigative Site
Santa Monica, California, United States
Novartis Investigative Site
Lakewood, Colorado, United States
Novartis Investigative Site
Boca Raton, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative site
Maywood, Illinois, United States
Novartis investigative site
Worcester, Massachusetts, United States
Novartis investigative site
Detroit, Michigan, United States
Novartis Investigative Site
New York, New York, United States
Novartis investigative site
Syracuse, New York, United States
Novartis investigative site
Durham, North Carolina, United States
Novartis investigative site
Medford, Oregon, United States
Novartis investigative site
Providence, Rhode Island, United States
Novartis Investigative Site
Concord, , Australia
Novartis Investigative Site
Fitzroy, , Australia
Novartis Investigative site
Geelong, , Australia
Novartis Investigative Site
Kogarah, , Australia
Novartis Investigative site
Maroochydore, , Australia
Novartis Investigative site
Nedlands, , Australia
Novartis Investigative Site
Calgary, , Canada
Novartis Investigative Site
London, , Canada
Novartis Investigative Site
Montreal, , Canada
Novartis Investigative Site
Ste-Foy, , Canada
Novartis Investigative Site
Toronto, , Canada
Novartis Investigative site
Auckland, , New Zealand
Novartis Investigative Site
Christchurch, , New Zealand
Novartis Investigative site
Salamanca, , Spain
Novartis Investigative site
Liverpool, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Novartis Investigative site
Nottingham, , United Kingdom
Novartis Investigative Site
Oxford, , United Kingdom
Novartis Investigative site
Penarth, , United Kingdom
Novartis investigative site
Pernarth, , United Kingdom
Novartis Investigative Site
Stanmore, , United Kingdom
Novartis Investigative Site
Vale of Glamorgan, , United Kingdom
Countries
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Other Identifiers
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ZOL446K2304
Identifier Type: OTHER
Identifier Source: secondary_id
CZOL446H2304
Identifier Type: -
Identifier Source: org_study_id
NCT00050258
Identifier Type: -
Identifier Source: nct_alias
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