N/A
N=3,304
Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT02089997 ↗Enrolled (actual)
3,304
Serious AEs
0.5%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) — 231 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
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) |
231 | — |
| SECONDARY Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment |
4.700 | — |
| SECONDARY Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment |
1.008 | — |
| SECONDARY Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment |
1.745 | — |
| SECONDARY Percent Change From Baseline in Radius BMD at Final Assessment |
1.173 | — |
| SECONDARY Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment |
-14.024 | — |
| SECONDARY Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment |
-32.016 | — |
| SECONDARY Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment |
-19.449 | — |
| SECONDARY Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment |
-46.302 | — |
| SECONDARY Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment |
-22.010 | — |
| SECONDARY Change From Baseline in Height |
-0.37 | — |
| SECONDARY Number of Participants Who Had Lumbar Backache at Final Assessment |
663 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen
Eligibility Criteria
Inclusion Criteria
- Osteoporosis patients
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02089997). 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.