Clinical trial NCT02106455: Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
Official title: Sodium Risedronate 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance -
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osseous Paget's Disease
Keywords: Pharmacological theapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 315
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Osseous Paget's disease

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Drug Reactions
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point
timeFrame: Baseline and final assessment point (Up to 48 weeks)
measure: Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point
timeFrame: Baseline and final assessment point (Up to 48 weeks)
measure: Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
timeFrame: Baseline and final assessment point (Up to 48 weeks)
measure: Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline
timeFrame: Baseline and final assessment point (Up to 48 weeks)
measure: Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline
timeFrame: Baseline and final assessment point (Up to 48 weeks)
measure: Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline
timeFrame: Baseline and final assessment point (Up to 48 weeks)
measure: Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point
timeFrame: Baseline and final assessment point (Up to 48 weeks)
measure: Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point
timeFrame: Baseline and final assessment point (Up to 48 weeks)
measure: Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point
timeFrame: Baseline and final assessment point (Up to 48 weeks)
measure: Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: