NCT02106455.

Trial name or title	Takeda Study Registration Call Center, post marketing Group Manager
Methods	Prospective cohort
Participants	Inclusion criteria: participants diagnosed with Paget's disease of bone treated with sodium risedronate tablets Exclusion criteria: No exclusions by age or gender Countries of recruitment: Japan
Interventions	Sodium risedronate tablets (Benet 17.5 mg) administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks.
Outcomes	Primary outcome: Frequency of adverse drug reactions (Time Frame: For 48 weeks). Adverse events are defined as any unfavourable 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 Secondary outcomes: Bone metabolism markers (Time Frame: From baseline to week 48) Pain associated with osseous Paget's disease (Time Frame: From baseline to week 48) Serum alkaline phosphatase (Time Frame: From baseline to week 48) Treatment compliance (Time Frame: From baseline to week 48)
Starting date	September 2008
Contact information	Telephone: 1‐800‐778‐2860 (USA & EU), email: medicalinformation@tpna.com
Ending date	Estimated study completion date: July 2017.
Target number of participants	2500
Identifier	ClinicalTrials.gov Identifier: NCT02106455
Notes	Sponsor information: Takeda