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36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets

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ClinicalTrials.gov Identifier: NCT02106442
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : July 17, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.

Condition or disease Intervention/treatment
Osteoporosis Drug: Sodium risedronate

Detailed Description:

This special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 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.


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Study Type : Observational
Actual Enrollment : 579 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets
Actual Study Start Date : May 13, 2013
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sodium Risedronate 75 mg
75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants receive sodium risedronate 75 mg as part of routine medical care.
Drug: Sodium risedronate
Sodium risedronate tablets




Primary Outcome Measures :
  1. Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures [ Time Frame: From baseline up to Month 36 ]
    The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.


Secondary Outcome Measures :
  1. Cumulative Percentage of Participants With Non-Vertebral Body Fractures [ Time Frame: From baseline up to Month 36 ]
    The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.

  2. Cumulative Percentage of Participants With Femur Fractures [ Time Frame: From baseline up to Month 36 ]
    The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.

  3. Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36) [ Time Frame: Baseline and final assessment (up to Month 36) ]
    BMD was measured by dual-energy X-ray absorptiometry.

  4. Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36) [ Time Frame: Baseline and final assessment (up to Month 36) ]
    BMD was measured by dual-energy X-ray absorptiometry.

  5. Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36) [ Time Frame: Baseline and final assessment (up to Month 36) ]
    BMD was measured by dual-energy X-ray absorptiometry.

  6. Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36) [ Time Frame: Baseline and final assessment (up to Month 36) ]
    BMD was measured by dual-energy X-ray absorptiometry.

  7. Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) [ Time Frame: Baseline and final assessment (up to Month 36) ]
  8. Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36) [ Time Frame: Baseline and final assessment (up to Month 36) ]
  9. Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36) [ Time Frame: Baseline and final assessment (up to Month 36) ]
  10. Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36) [ Time Frame: Baseline and final assessment (up to Month 36) ]
  11. Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) [ Time Frame: Baseline and final assessment (up to Month 36) ]
  12. Change From Baseline in Height at Final Assessment (up to Month 36) [ Time Frame: Baseline and final assessment (up to Month 36) ]
  13. Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36) [ Time Frame: Final assessment (up to Month 36) ]
  14. Number of Participants Who Had One or More Adverse Drug Reactions [ Time Frame: Up to Month 36 ]
    Adverse drug reaction refers to adverse events related to the administered drug.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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 sodium risedronate 75 mg tablets)
  2. Male and postmenopausal female patients aged 50 years or older
  3. Ambulatory outpatients

Exclusion Criteria:

-


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
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Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] June 2, 2017
Statistical Analysis Plan  [PDF] November 17, 2017


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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02106442     History of Changes
Other Study ID Numbers: 178-002
JapicCTI-142479 ( Registry Identifier: JapicCTI )
First Posted: April 8, 2014    Key Record Dates
Results First Posted: July 17, 2019
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Pharmacological therapy
Additional relevant MeSH terms:
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Osteoporosis
Fractures, Bone
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Wounds and Injuries
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