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

Overview

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.

Full Title of Study: “36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2018

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.

Interventions

  • Drug: Sodium risedronate
    • Sodium risedronate tablets

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Change From Baseline in Height at Final Assessment (up to Month 36)
    • Time Frame: Baseline and final assessment (up to Month 36)
  • Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
    • Time Frame: Final assessment (up to Month 36)
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda

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