Introduction
Materials and methods
Study design
Patients
Treatments
Efficacy assessments
Safety assessments
Statistical analysis
Results
Subjects
Efficacy assessments
Safety assessments
Risedronate | ||
---|---|---|
5-mg daily | 150-mg once a month | |
(N = 642) | (N = 650) | |
n (%) |
n (%) | |
AEs | 554 (86.3) | 578 (88.9) |
Serious AEs | 51 (7.9) | 77 (11.8) |
Deaths | 4 (0.6) | 0 |
Withdrawn due to an AE | 84 (13.1) | 80 (12.3) |
Most common AE associated with withdrawal | ||
Gastrointestinal disorder | 49 (7.6) | 47 (7.2) |
Most common AEs | ||
Influenza | 57 (8.9) | 94 (14.5) |
Nasopharyngitis | 62 (9.7) | 70 (10.8) |
Diarrhea | 43 (6.7) | 69 (10.6) |
Arthralgia | 68 (10.6) | 65 (10.0) |
Back pain | 80 (12.5) | 65 (10.0) |
Bronchitis | 68 (10.6) | 57 (8.8) |
AEs of special interest | ||
Clinical vertebral fracture | 6 (0.9) | 4 (0.6) |
Nonvertebral fracture | 25 (3.9) | 28 (4.3) |
Upper gastrointestinal tract AEs | 148 (23.1) | 169 (26.0) |
Selected musculoskeletal AEsa
| 172 (26.8) | 163 (25.1) |
Atrial fibrillation | 1 (0.2) | 3 (0.5) |
Neoplasmsb
| 23 (3.6) | 25 (3.8) |