Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance −
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|ClinicalTrials.gov Identifier: NCT02106455|
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment|
|Osseous Paget's Disease||Drug: Sodium risedronate|
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.
|Study Type :||Observational|
|Actual Enrollment :||2500 participants|
|Official Title:||Benet 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance −|
|Actual Study Start Date :||May 27, 2013|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106455
|Study Chair:||Postmarketing Group Manager||Takeda|