Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -

Takeda

Status: Completed

Conditions: Osseous Paget's Disease

Treatments: Drug: Sodium risedronate

Study type: Observational

Funder types: Industry

Identifiers

NCT02106455

067-211

JapicCTI-142480 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.

Full description

This special drug use surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets 17.5 mg administered once daily (one tablet per dose) in patients with osseous Paget's disease in daily medical practice.

The usual dosage for adults is 17.5 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. For at least 30 minutes after administration, participants should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.

Enrollment: 315 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg

Exclusion criteria

Trial design

315 participants in 1 patient group

17.5 mg of sodium risedronate

Description:

17.5 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks.

Treatment:

Drug: Sodium risedronate