Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine the status of treatment compliance - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen

Detailed Description
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This surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) as well as to evaluate the status of treatment compliance 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.

Official Title
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Benet 75 mg Tablets Special Drug Use Surveillance: Long-term Use (12-month Treatment Survey)

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 Exclusion Criteria: None
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 |
| --- | --- |
| 75 mg of sodium risedronate<br>75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. | Drug: Sodium Risedronate<br>* Sodium risedronate tablets<br>* Other names: Benet 75mg Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs 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 the treatment. | Up to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. | Baseline and final assessment (up to Month 12) | 
| Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the femur (neck region) at end of study relative to baseline. | Baseline and final assessment (up to Month 12) | 
| Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at end of study relative to baseline. | Baseline and final assessment (up to Month 12) | 
| Percent Change From Baseline in Radius BMD at Final Assessment | BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the radius at end of study relative to baseline. | Baseline and final assessment (up to Month 12) | 
| Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | Baseline and final assessment (up to Month 12) | 
| Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | Baseline and final assessment (up to Month 12) | 
| Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | Baseline and final assessment (up to Month 12) | 
| Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | Baseline and final assessment (up to Month 12) | 
| Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule. | Baseline and final assessment (up to Month 12) | 
| Change From Baseline in Height |  | Baseline and final assessment (up to Month 12) | 
| Number of Participants Who Had Lumbar Backache at Final Assessment |  | Final assessment (Month 12) | 

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