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Trial record 1 of 1 for:    178-002
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36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate Tablets

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02106442
First Posted: April 8, 2014
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
The purpose of this study is to evaluate the efficacy (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets (Benet 75 mg Tablets) for 36 months in osteoporosis patients in daily medical practice.

Condition Intervention
Osteoporosis Drug: Sodium risedronate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Frequency of vertebral body fractures [ Time Frame: From baseline to Month 36 ]
    Frequency of vertebral body fractures will be tabulated for the efficacy analysis set.


Secondary Outcome Measures:
  • Frequency of nonvertebral body fractures [ Time Frame: From baseline to Month 36 ]
    Frequency of nonvertebral body fractures will be tabulated for the efficacy analysis set.

  • Rate of change from baseline in bone density [ Time Frame: From baseline to Month 36 ]
    Tabulation of percent change in bone density for the efficacy analysis set

  • Rate of change from baseline in bone metabolism markers [ Time Frame: From baseline to Month 36 ]
    Tabulation of percent change in bone metabolism markers for the efficacy analysis set

  • Time course from baseline in height [ Time Frame: From baseline to Month 36 ]
    Tabulation of change in height for the efficacy analysis set

  • Change from baseline in lumbar backache [ Time Frame: From baseline to Month 36 ]
    Tabulation of change in lumbar backache for the efficacy analysis set

  • Frequency of adverse events [ Time Frame: For 36 months ]
    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.


Enrollment: 500
Actual Study Start Date: May 27, 2013
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: April 30, 2018 (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 special drug use surveillance was designed to evaluate the efficacy (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate tablets (Benet 75 mg Tablets) 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

Information from the National Library of Medicine

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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 who meet all the following criteria:

    1. Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of Benet 75 mg Tablets)
    2. Male and postmenopausal female patients aged 50 years or older
    3. Ambulatory outpatients

      Exclusion Criteria:

  Contacts and Locations
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): NCT02106442


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: NCT02106442     History of Changes
Other Study ID Numbers: 178-002
JapicCTI-142479 ( Registry Identifier: JapicCTI )
First Submitted: April 3, 2014
First Posted: April 8, 2014
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
Osteoporosis
Fractures, Bone
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Wounds and Injuries
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs