Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance −
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Benet 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance −|
- Frequency of adverse drug reactions [ Time Frame: For 48 weeks ]The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with sodium risedronate are defined as adverse drug reactions.
- Serum ALP [ Time Frame: From Baseline to Week 48 ]Percent change from Baseline in serum ALP will be tabulated.
- Bone metabolism markers [ Time Frame: From Baseline to Week 48 ]Percent changes from Baseline in bone metabolism markers will be tabulated.
- Pain associated with osseous Paget's disease [ Time Frame: From Baseline to Week 48 ]Distribution of severity of pain associated with osseous Paget's disease will be tabulated.
- Treatment compliance [ Time Frame: From Baseline to Week 48 ]Treatment compliance during the treatment period will be tabulated.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
17.5 mg of sodium risedronate
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.
Drug: Sodium risedronate
Sodium risedronate tablets
Other Name: Benet 17.5mg Tablets
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02106455
|Study Chair:||Postmarketing Group Manager||Takeda|