Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -

Study Overview
=================
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.

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 -

Conditions
-----------------
Osseous Paget's Disease

Intervention / Treatment
-----------------
* Drug: Sodium risedronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 17.5 mg of sodium risedronate<br>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<br>* Sodium risedronate tablets<br>* Other names: Actonel 17.5mg Tablets;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Had One or More Adverse Drug Reactions | Adverse drug reaction refers to adverse events related to administered drug. | Up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point | Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported. | Baseline and final assessment point (Up to 48 weeks) | 
| Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point | Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported. | Baseline and final assessment point (Up to 48 weeks) | 
| Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Investigators marked severity of pain with a 4-point scale ranging from None to Very Severe (None, Mild, Severe, Very Severe) at baseline and the final assessment point. This scale was specified on the protocol of this observational study. The reported data were number of participants stratified by comparison of pain severity between baseline and final assessment point described as None (at baseline) to Severe (at final assessment point). | Baseline and final assessment point (Up to 48 weeks) | 
| Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline | Investigator marked assessment of image findings of bone morphogenic abnormalities at final assessment point compared with baseline as follows; improved, unchanged, worsened. The reported data were the number of participants stratified by assessment of image findings at final assessment point. | Baseline and final assessment point (Up to 48 weeks) | 
| Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline | Investigator marked assessment of image findings of trabecular bone structural abnormalities at final assessment point compared with baseline as follows; improved, unchanged, worsened. The reported data were the number of participants stratified by assessment of image findings at final assessment point. | Baseline and final assessment point (Up to 48 weeks) | 
| Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline | Other Abnormalities refer to bone abnormal findings excluding bone morphogenic abnormalities and trabecular bone structural abnormalities (see Outcome Measure 5 and 6). Investigator marked assessment of image findings of other abnormalities at final assessment point compared with baseline as follows; improved, unchanged, worsened. The reported data were the number of participants stratified by assessment of image findings at final assessment point. | Baseline and final assessment point (Up to 48 weeks) | 
| Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point | Percentage of changes from baseline in urinary NTX level at final assessment point (up to 48 weeks) was reported. Urinary NTX is one of bone metabolism markers. | Baseline and final assessment point (Up to 48 weeks) | 
| Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point | Percentage of changes from baseline in urinary DPD level at final assessment point (up to 48 weeks) was reported. Urinary DPD is one of bone metabolism markers. | Baseline and final assessment point (Up to 48 weeks) | 
| Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point | Percentage of changes from baseline in serum BAP level at final assessment point (up to 48 weeks) was reported. Serum BAP is one of bone metabolism markers. | Baseline and final assessment point (Up to 48 weeks) | 
| Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period | Treatment compliance of this outcome measure refers to the percentage of participants who correctly follow medication. The reported data are percentage of participants in the classification including 4 specific degrees of treatment compliance; 90 % or more; 67 % or more and <90 %; 25 % or more and <67 %; less than 25 % or unknown. | Up to 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacological theapy