Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®
NCT ID: NCT00668200
Last Updated: 2015-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
81 participants
INTERVENTIONAL
2008-05-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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zoledronic acid
5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
Reclast (ZOL446, zoledronic acid)
5 mg i.v. annually ("real-life, physician prescribed")
Calcium
1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)
Vitamin D
800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration
Interventions
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Reclast (ZOL446, zoledronic acid)
5 mg i.v. annually ("real-life, physician prescribed")
Calcium
1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)
Vitamin D
800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* As per currently approved Reclast® Package Insert:
Exclusion Criteria
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
Phoenix, Arizona, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Gainesville, Georgia, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
Syracuse, New York, United States
Novartis Investigative Site
Providence, Rhode Island, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Waco, Texas, United States
Novartis Investigative Site
Madison, Wisconsin, United States
Countries
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Related Links
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Related Info
Other Identifiers
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CZOL446K2401
Identifier Type: -
Identifier Source: org_study_id
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