N/A
N=579
36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT02106442 ↗Enrolled (actual)
579
Serious AEs
0.7%
Results posted
Jul 2019
Primary outcome: Primary: Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures — 5.43; 7.35; 7.80; 8.82 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sodium risedronate (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures |
5.43; 7.35; 7.80; 8.82; 9.97; 12.58 | — |
| SECONDARY Cumulative Percentage of Participants With Non-Vertebral Body Fractures |
1.72; 2.78; 3.40; 4.11; 6.15; 6.59 | — |
| SECONDARY Cumulative Percentage of Participants With Femur Fractures |
0.19; 0.46; 0.78; 1.14; 1.14; 1.58 | — |
| SECONDARY Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36) |
6.848 | — |
| SECONDARY Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36) |
1.067 | — |
| SECONDARY Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36) |
1.496 | — |
| SECONDARY Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36) |
3.498 | — |
| SECONDARY Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) |
-15.756 | — |
| SECONDARY Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36) |
-15.539 | — |
| SECONDARY Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36) |
-20.023 | — |
| SECONDARY Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36) |
-40.838 | — |
| SECONDARY Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) |
-25.285 | — |
| SECONDARY Change From Baseline in Height at Final Assessment (up to Month 36) |
-0.82 | — |
| SECONDARY Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36) |
116 | — |
| SECONDARY Number of Participants Who Had One or More Adverse Drug Reactions |
57 | — |
Summary
The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.
Eligibility Criteria
Inclusion Criteria
Osteoporosis patients who meet all the following criteria:
- Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets)
- Male and postmenopausal female patients aged 50 years or older
- Ambulatory outpatients
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT02106442). 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.