Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance −

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 17.5 mg Tablets) administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.

Condition or disease	Intervention/treatment
Osseous Paget's Disease	Drug: Sodium risedronate

Detailed Description:

This special drug use surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets (Benet 17.5 mg Tablets) administered once daily (one tablet per dose) in patients with osseous Paget's disease in daily medical practice.

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, patients should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.

Study Design

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Study Type :	Observational
Actual Enrollment :	2500 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Benet 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance −
Actual Study Start Date :	May 27, 2013
Actual Primary Completion Date :	July 31, 2017
Actual Study Completion Date :	July 31, 2017

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
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.	Drug: Sodium risedronate; Sodium risedronate tablets; Other Name: Benet 17.5mg Tablets

Outcome Measures

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Primary Outcome Measures :

1. Frequency of adverse drug reactions [ Time Frame: For 48 weeks ]
   The frequencies of all adverse events 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 treatment. Among these, events that are considered as having a causal relationship with sodium risedronate are defined as adverse drug reactions.

Secondary Outcome Measures :

1. Serum ALP [ Time Frame: From Baseline to Week 48 ]
   Percent change from Baseline in serum ALP will be tabulated.
2. Bone metabolism markers [ Time Frame: From Baseline to Week 48 ]
   Percent changes from Baseline in bone metabolism markers will be tabulated.
3. Pain associated with osseous Paget's disease [ Time Frame: From Baseline to Week 48 ]
   Distribution of severity of pain associated with osseous Paget's disease will be tabulated.
4. Treatment compliance [ Time Frame: From Baseline to Week 48 ]
   Treatment compliance during the treatment period will be tabulated.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Osseous Paget's disease

Criteria

Inclusion Criteria:

• Osseous Paget's disease patients treated with sodium risedronate tablets (Benet 17.5 mg Tablets)

Exclusion Criteria:

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Japan
Osaka, Japan
Tokyo, Japan

Sponsors and Collaborators

Takeda

Investigators

Study Chair:	Postmarketing Group Manager	Takeda

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Takeda
ClinicalTrials.gov Identifier:	NCT02106455 History of Changes
Other Study ID Numbers:	067-211; JapicCTI-142480 ( Registry Identifier: JapicCTI )
First Posted:	April 8, 2014
Last Update Posted:	August 1, 2017
Last Verified:	July 2017

Keywords provided by Takeda:

Pharmacological theapy

Additional relevant MeSH terms:

Osteitis Deformans; Bone Diseases; Musculoskeletal Diseases; Risedronate Sodium; Etidronic Acid	Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Bone Density Conservation Agents; Physiological Effects of Drugs