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

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Sodium Risedronate

• Registration Number: NCT02089997
• Lead Sponsor: Takeda

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-05-27
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-18
• Primary Completion: 2016-04-30
• Study Completion: 2016-04-30
• Results First Submitted: 2017-07-27
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-02
• Last Update Submitted: 2018-02-02
• Results First Posted: 2018-10-19
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3304

Inclusion Criteria

• Osteoporosis patients

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
75 mg of sodium risedronate	Sodium Risedronate	75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)	Up to Month 12	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.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment	Baseline and final assessment (up to Month 12)	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.
Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment	Baseline and final assessment (up to Month 12)	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.
Percent Change From Baseline in Radius BMD at Final Assessment	Baseline and final assessment (up to Month 12)	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.
Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment	Baseline and final assessment (up to Month 12)	Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment	Baseline and final assessment (up to Month 12)	Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment	Baseline and final assessment (up to Month 12)	Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule.
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)
Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment	Baseline and final assessment (up to Month 12)	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.
Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment	Baseline and final assessment (up to Month 12)	Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment	Baseline and final assessment (up to Month 12)	Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.