36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets

Takeda

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: Sodium risedronate

Study type: Observational

Funder types: Industry

Identifiers

NCT02106442

178-002

JapicCTI-142479 (Registry Identifier)

Details and patient eligibility

About

The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.

Full description

This special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 75 mg tablets 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.

Enrollment: 579 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Osteoporosis patients who meet all the following criteria:

1. Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets)
2. Male and postmenopausal female patients aged 50 years or older
3. Ambulatory outpatients

Exclusion criteria

Trial design

579 participants in 1 patient group

Sodium Risedronate 75 mg

Description:

75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants receive sodium risedronate 75 mg as part of routine medical care.

Treatment:

Drug: Sodium risedronate