Overview

This trial is active, not recruiting.

Condition osseous paget's disease
Treatment sodium risedronate
Sponsor Takeda
Start date May 2013
End date April 2018
Trial size 2500 participants
Trial identifier NCT02106455, 067-211, JapicCTI-142480

Summary

The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 17.5 mg Tablets) administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
sodium risedronate Benet 17.5mg Tablets
Sodium risedronate tablets

Primary Outcomes

Measure
Frequency of adverse drug reactions
time frame: For 48 weeks

Secondary Outcomes

Measure
Serum ALP
time frame: From Baseline to Week 48
Bone metabolism markers
time frame: From Baseline to Week 48
Pain associated with osseous Paget's disease
time frame: From Baseline to Week 48
Treatment compliance
time frame: From Baseline to Week 48

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Osseous Paget's disease patients treated with sodium risedronate tablets (Benet 17.5 mg Tablets) Exclusion Criteria:

Additional Information

Official title Benet 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance −
Description This special drug use surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets (Benet 17.5 mg Tablets) 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, patients should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Takeda.