Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
NCT ID: NCT02106455
Last Updated: 2019-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
315 participants
OBSERVATIONAL
2008-08-01
2017-10-24
Brief Summary
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Detailed Description
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The usual dosage for adults is 17.5 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. For at least 30 minutes after administration, participants should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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17.5 mg of sodium risedronate
17.5 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks.
Sodium risedronate
Sodium risedronate tablets
Interventions
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Sodium risedronate
Sodium risedronate tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Osaka, , Japan
Tokyo, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JapicCTI-142480
Identifier Type: REGISTRY
Identifier Source: secondary_id
067-211
Identifier Type: -
Identifier Source: org_study_id
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