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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Sodium risedronate


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sodium Risedronate 75 mg<br>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<br>* Sodium risedronate tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures | 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. | From baseline up to Month 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Percentage of Participants With Non-Vertebral Body Fractures | 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. | From baseline up to Month 36 | 
| Cumulative Percentage of Participants With Femur Fractures | 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. | From baseline up to Month 36 | 
| Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | Baseline and final assessment (up to Month 36) | 
| Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | Baseline and final assessment (up to Month 36) | 
| Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | Baseline and final assessment (up to Month 36) | 
| Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | Baseline and final assessment (up to Month 36) | 
| Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) |  | 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) |  | 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) |  | 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) |  | 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) |  | Baseline and final assessment (up to Month 36) | 
| Change From Baseline in Height at Final Assessment (up to Month 36) |  | Baseline and final assessment (up to Month 36) | 
| Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36) |  | Final assessment (up to Month 36) | 
| Number of Participants Who Had One or More Adverse Drug Reactions | Adverse drug reaction refers to adverse events related to the administered drug. | Up to Month 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacological therapy