NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Osseous Paget's disease
Date of first enrollment	03/9/2008
Target sample size	2500
Countries of recruitment
Study type	OBSERVATIONAL
Intervention(s)	Intervention name : Benet 17.5 mg Tablets (sodium risedronate) Dosage And administration of the intervention : The usual dosage for adults is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly 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. Control intervention name : null

Outcome(s)

Primary Outcome

Frequency of adverse drug reactions Primary timeframe For 48 weeks The frequencies of all adverse drug reactions 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 the treatment. Among these, events that are considered as having a causal relationship with sodium risedronate are defined as adverse drug reactions.

Secondary Outcome

Serum ALP, bone metabolism markers, pain associated with osseous Paget's disease, and treatment compliance Secondary timeframe From Baseline to Week 48 The following parameters will be tabulated: [1] Rate of changes from Baseline in serum ALP level and bone metabolism markers [2] Distribution of severity of pain associated with osseous Paget's disease [3] Treatment compliance

Key inclusion & exclusion criteria

Age minimum
Age maximum
Gender	BOTH
Include criteria	Osseous Paget's disease patients treated with Benet 17.5 mg Tablets
Exclude criteria