NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142480

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedOsseous Paget's disease
Date of first enrollment03/9/2008
Target sample size2500
Countries of recruitment
Study typeOBSERVATIONAL
Intervention(s)Intervention name : Benet 17.5 mg Tablets (sodium risedronate) Dosage And administration of the intervention : The usual dosage for adults is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking for 8 consecutive weeks. For at least 30 minutes after administration, patients should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs. Control intervention name : null

Outcome(s)

Primary OutcomeFrequency of adverse drug reactions Primary timeframe For 48 weeks The frequencies of all adverse drug reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate whether or not it was considered related to the treatment. Among these, events that are considered as having a causal relationship with sodium risedronate are defined as adverse drug reactions.
Secondary OutcomeSerum ALP, bone metabolism markers, pain associated with osseous Paget's disease, and treatment compliance Secondary timeframe From Baseline to Week 48 The following parameters will be tabulated: [1] Rate of changes from Baseline in serum ALP level and bone metabolism markers [2] Distribution of severity of pain associated with osseous Paget's disease [3] Treatment compliance

Key inclusion & exclusion criteria

Age minimum
Age maximum
GenderBOTH
Include criteriaOsseous Paget's disease patients treated with Benet 17.5 mg Tablets
Exclude criteria

Related Information

Contact

public contact
Name Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
Address https://www.takeda.co.jp/contact/form/jp/form/
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