Table 1.
Selected Phase III and post-marketing clinical trials of denosumab
| Study | Description | Primary Endpoint | Number of subjects | Efficacy results | Safety Results |
|---|---|---|---|---|---|
| FREEDOM [20] | Treatment of postmenopausal osteoporosis (denosumab vs. placebo) | New vertebral fractures at 36 months | 7868 | Denosumab reduced vertebral fracture risk | Similar AEs and SAEs, though cellulitis and eczema increased with denosumab |
| FREEDOM extension[31] | 5 years of extension data beyond the 3-year FREEDOM trial | Efficacy and safety | 2678 at 8 years of therapy | Continued reduction of vertebral and non-vertebral fracture risk | No new safety concerns during extension |
| ADAMO [38] | Treatment of osteoporosis in males (denosumab vs. placebo) | Change in LS BMD at 12 months | 242 | Greater BMD increase with denosumab | Similar AEs and SAEs |
| HALT [39] | Treatment of bone density loss in men undergoing androgen-deprivation therapy for non-metastatic, hormone-sensitive prostate cancer (denosumab vs. placebo) | Change in LS BMD at 24 months | 1468 | Greater BMD increase with denosumab. Decreased incidence of new vertebral fractures at 36 months |
Similar AEs and SAEs |
| Denosumab in women receiving adjuvant aromataseiInhibitors for non-metastatic breast cancer [40] | Treatment of bone density loss in women with hormone receptor-positive non-metastatic breast cancer treated with adjuvant aromatase inhibitor (denosumab vs. placebo) | Change in LS BMD at 12 months | 252 | Greater BMD increase with denosumab | Similar AEs and SAEs |
| DATA [41] | Treatment of post-menopausal osteoporosis (teriparatide vs. denosumab vs. combination) | Change in LS BMD at 24 months | 94 | Greater BMD increase with combination therapy compared to single therapy | Similar AEs and SAEs |
| DAPS [44] | Patient satisfaction and adherence to treatment in post-menopausal women (denosumab vs. alendronate) | Proportion of subjects adherent to treatment at 1 year | 221 | Greater patient adherence to and satisfaction with denosumab | Similar AEs and SAEs |
ADAMO: Study to compare the efficacy and safety of denosumab versus placebo in males with osteoporosis; AE: Adverse event; BMD: Bone mineral density; DAPS: Denosumab adherence preference satisfaction; DATA: Denosumab and teriparatide administration study; FREEDOM: Fracture reduction evaluation of denosumab in osteoporosis every 6 Months; LS: Lumbar spine; SAE: Serious adverse event;