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Trial record 1 of 1 for:    067-211
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Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance −

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02106455
First received: April 3, 2014
Last updated: August 31, 2016
Last verified: August 2016
  Purpose
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 Intervention
Osseous Paget's Disease Drug: Sodium risedronate

Study Type: Observational
Study Design: 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 −

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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:
  • Serum ALP [ Time Frame: From Baseline to Week 48 ]
    Percent change from Baseline in serum ALP will be tabulated.

  • Bone metabolism markers [ Time Frame: From Baseline to Week 48 ]
    Percent changes from Baseline in bone metabolism markers will be tabulated.

  • 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.

  • Treatment compliance [ Time Frame: From Baseline to Week 48 ]
    Treatment compliance during the treatment period will be tabulated.


Estimated Enrollment: 2500
Study Start Date: May 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02106455

Locations
Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02106455     History of Changes
Other Study ID Numbers: 067-211
JapicCTI-142480 ( Registry Identifier: JapicCTI )
Study First Received: April 3, 2014
Last Updated: August 31, 2016

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

ClinicalTrials.gov processed this record on June 22, 2017