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Completed

NCT Number: NCT02106442

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Osteoporosis patients who meet all the following criteria:

  • 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)
  • Male and postmenopausal female patients aged 50 years or older
  • Ambulatory outpatients

Exclusion criteria

-

Treatment and study plan

Sodium risedronate

Drug

Sodium risedronate tablets

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 8, 2014
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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