N/A
N=315
Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
Osseous Paget's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02106455 ↗Enrolled (actual)
315
Serious AEs
4.9%
Results posted
Jun 2019
Primary outcome: Primary: Percentage of Participants Who Had One or More Adverse Drug Reactions — 14.98 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sodium risedronate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had One or More Adverse Drug Reactions |
14.98 | — |
| SECONDARY Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point |
-72.47 | — |
| SECONDARY Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point |
-31.71 | — |
| SECONDARY Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point |
138; 1; 1; 12; 14; 18 | — |
| SECONDARY Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline |
7; 66; 1 | — |
| SECONDARY Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline |
14; 57; 1 | — |
| SECONDARY Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline |
6; 31; 2 | — |
| SECONDARY Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point |
-51.01 | — |
| SECONDARY Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point |
-10.01 | — |
| SECONDARY Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point |
-43.57 | — |
| SECONDARY Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period |
95.11; 2.61; 0.65; 0.33; 1.30 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT02106455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.