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

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ClinicalTrials.gov Identifier: NCT02106455
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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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Ages Eligible for Study:   Child, Adult, Older Adult
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106455


Locations
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Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Chair: Postmarketing Group Manager Takeda
More Information
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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    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Takeda:
Pharmacological theapy

Additional relevant MeSH terms:
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Osteitis Deformans
Bone Diseases
Musculoskeletal Diseases
Risedronic Acid
Etidronic Acid
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents