Table 3.
Treatment-emergent adverse effects during the follow-up period.
| Adverse event | Groups |
Comparison between groups | |
|---|---|---|---|
| DB | ZA | ||
| Intervention | Denosumab | Zoledronic acid | |
| Sample size | 125 | 125 | p-value |
| Arthralgia (joint pain) | 25 (20) | 27 (22) | 0.872 |
| Fatigue | 24 (19)√ | 5 (4) | 0.0004 |
| Headache | 24 (19) | 26 (20) | 0.87 |
| Pain in extremity | 22 (18) | 20 (16) | 0.866 |
| Nausea | 30 (24) | 33 (26) | 0.771 |
| Back pain | 27 (22)√ | 1 (1) | <0.0001 |
| Depression | 1 (1) | 2 (2) | 0.561 |
| Musculoskeletal pain | 1 (1) | 1 (1) | N/A |
| aHypocalcemia | 9 (7) | 45 (36)× | <0.0001 |
| Vomiting | 1 (1) | 5 (4) | 0.215 |
| Constipation | 1 (1) | 1 (1) | N/A |
| Flu-like symptoms | 0 (0) | 7 (6)× | 0.021 |
| Shortness of breath | 0 (0) | 2 (2) | 0.478 |
| Diarrhea | 1 (1) | 1 (1) | N/A |
| Loss of appetite | 3 (2) | 5 (4) | 0.719 |
| Cough | 0 (0) | 1 (1) | 0.316 |
| Dizziness | 0 (0) | 1 (1) | 0.316 |
| Insomnia | 0 (0) | 1 (1) | 0.316 |
| Abdominal pain | 0 (0) | 2 (2) | 0.478 |
| Paresthesia | 0 (0) | 2 (2) | 0.478 |
| Urinary tract infection | 0 (0) | 2 (2) | 0.478 |
| Alopecia | 5 (4) | 5 (4) | N/A |
| Osteonecrosis of the jaw | 4 (3) | 1 (1) | 0.366 |
| bHypophosphatemia | 6 (5) | 13 (10) | 0.152 |
| Weight gain | 1 (1) | 0 (0) | 0.316 |
| cAnemia | 2 (2) | 4 (3) | 0.679 |
| Infections (non-specific) | 5 (4) | 6 (5) | 0.758 |
| Osteomyelitis | 3 (3) | 0 (0) | 0.254 |
| Ostealgia | 0 (0) | 4 (3) | 0.131 |
| Decreased kidney function | 0 (0) | 3 (2) | 0.245 |
| Weight loss | 0 (0) | 5 (4) | 0.071 |
| dHypokalemia | 0 (0) | 7 (6)× | 0.021 |
| Candidiasis | 0 (0) | 1 (1) | 0.316 |
| eHypotension | 0 (0) | 7 (6)× | 0.021 |
| fHypomagnesemia | 0 (0) | 1 (1) | 0.316 |
| Dysphasia | 0 (0) | 1 (1) | 0.316 |
| gFever | 0 (0) | 5 (4) | 0.071 |
All clinical parameters were evaluated by one pathologist, one nephrologist, one hepatologist, one physician, and one hematologist (all with ≥3 years of experience).
N/A: not applicable.
Evaluation as per CTCAEv5.0 guidelines.
Data are represented as numbers (percentage).
Chi-square independence tests were used for the statistical analysis. p < 0.05 was considered significant.
Blood serum calcium concentration <2.1 mM/L.
Serum phosphate concentration <2.5 mg/dL (0.81 mM/L).
Hemoglobin level <13.5 g/100 mL for men and <12.0 g/100 mL for women.
Blood serum potassium level <3.5 mM/L.
Blood pressure <90/60 mmHg.
Serum magnesium concentration <1.8 mg/dL (0.70 mM/L).
Body temperature ≥100.4 °F (38 °C) with chills.
Significant denosumab-emergent adverse effects.
Significant zoledronic-acid-emergent adverse effects.