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

Takeda

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: Sodium Risedronate

Study type: Observational

Funder types: Industry

Identifiers

NCT02089997

178-001

JapicCTI-142463 (Registry Identifier)

JapicCTI-R171017 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,304 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoporosis patients

Exclusion criteria

• None

Trial design

3,304 participants in 1 patient group

75 mg of sodium risedronate

Description:

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

Treatment:

Drug: Sodium Risedronate