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Trial record 1 of 2 for:    178-001
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Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02089997
First received: March 14, 2014
Last updated: July 14, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen

Condition Intervention
Osteoporosis Drug: Sodium risedronate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Benet 75 mg Tablets Special Drug Use Surveillance: Long-term Use (12-month Treatment Survey)

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Frequency of adverse events [ Time Frame: For 12 months ]
    The frequency of all adverse events observed during the observation period will be tabulated by symptom, 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.


Secondary Outcome Measures:
  • Change rate from baseline in bone density [ Time Frame: Pretreatment (within 3 months before the start of treatment), 6 months after, and 12 months after the start of treatment (or at the time of withdrawal) ]
    Tabulation of percent change in bone density for the efficacy analysis set

  • Change rate from baseline in bone metabolism markers [ Time Frame: Pretreatment (within 1 month before the start of treatment), 6 months after, and 12 months after the start of treatment (or at the time of withdrawal) ]
    Tabulation of percent change in bone metabolism markers for the efficacy analysis set

  • Time cource from baseline in height [ Time Frame: At the start of treatment and 12 months after the start of treatment (or at the time of withdrawal) ]
    Tabulation of change in height for the efficacy analysis set

  • Change from baseline in lumbar backache [ Time Frame: At the start of treatment, 3 months after, 6 months after, and 12 months after the start of treatment (or at the time of withdrawal) ]
    Tabulation of change in lumbar backache for the efficacy analysis set


Enrollment: 1428
Study Start Date: May 2013
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
75 mg of sodium risedronate
75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.
Drug: Sodium risedronate
Sodium risedronate tablets
Other Name: Benet 75mg Tablets

Detailed Description:

This surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) as well as to evaluate the status of treatment compliance in osteoporosis patients in daily medical practice.

The usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. For at least 30 minutes after administration, patients should avoid lying in a supine position and should avoid taking food, drink (except for water) or other oral drugs. For more details, see the "Precautions related to dosage and administration" section of the package insert.

  Eligibility

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

Inclusion Criteria:

  • Osteoporosis patients

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: NCT02089997

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: NCT02089997     History of Changes
Other Study ID Numbers: 178-001
JapicCTI-142463 ( Registry Identifier: JapicCTI )
Study First Received: March 14, 2014
Last Updated: July 14, 2016

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
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 August 18, 2017