Overview

This trial is active, not recruiting.

Condition osteoporosis
Treatment sodium risedronate
Sponsor Takeda
Start date May 2013
End date April 2018
Trial size 275 participants
Trial identifier NCT02106442, 178-002, JapicCTI-142479

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.
sodium risedronate Benet 75mg Tablets
Sodium risedronate tablets

Primary Outcomes

Measure
Frequency of vertebral body fractures
time frame: From baseline to Month 36

Secondary Outcomes

Measure
Frequency of nonvertebral body fractures
time frame: From baseline to Month 36
Rate of change from baseline in bone density
time frame: From baseline to Month 36
Rate of change from baseline in bone metabolism markers
time frame: From baseline to Month 36
Time course from baseline in height
time frame: From baseline to Month 36
Change from baseline in lumbar backache
time frame: From baseline to Month 36
Frequency of adverse events
time frame: For 36 months

Eligibility Criteria

Male or female participants of any age.

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 Benet 75 mg Tablets) 2. Male and postmenopausal female patients aged 50 years or older 3. Ambulatory outpatients Exclusion Criteria:

Additional Information

Official title 36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets
Description This special drug use surveillance was designed to evaluate the efficacy (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate tablets (Benet 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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Takeda.