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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089997
• Other study ID #: 178-001
• Secondary ID: JapicCTI-142463J
• Status: Completed
• Start date: May 27, 2013
• Est. completion date: April 30, 2016

Study information

• Verified date: February 2018
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3304
• Est. completion date: April 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Osteoporosis patients

Exclusion Criteria:

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Sodium Risedronate
Sodium risedronate tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change From Baseline in Height		Baseline and final assessment (up to Month 12)
Secondary	Number of Participants Who Had Lumbar Backache at Final Assessment		Final assessment (Month 12)