Table 1.
Clinical trials investigating the effects of denosumab
| Study name or title on http://www.clinicaltrials.gov | Phase | n | Primary end-point |
| Osteoporosis | |||
| A single dose, placebo-controlled study of AMG 162, a fully human mAb to RANKL, in postmenopausal women [6] | phase 1 | 49 | Pharmacokinetics and pharmacodynamics |
| A randomized, double-blind, placebo-controlled, multidose phase 2 study to determine the efficacy, safety, and tolerability of AMG 162 in the treatment of postmenopausal women with low BMD [14] | phase 2 | 412 | BMD |
| A randomized, double-blind, placebo-controlled, dose-response study of AMG 162 (denosumab) in Japanese postmenopausal osteoporotic women | phase 2 | - | BMD |
| A multicenter, randomized, placebo-controlled, pilot microCT study to estimate the effect of treatment with denosumab (AMG 162) and alendronate sodium in postmenopausal women with low BMD | phase 2 | 240 | Distal radius measurements as determined by Xtreme CT |
| A study to evaluate AMG 162 in the treatment of postmenopausal osteoporosis | phase 3 | 7,800 | Fracture |
| A randomized, double-blind study to compare the efficacy of treatment with denosumab with that of alendronate sodium in postmenopausal women with low BMD | phase 3 | 1,100 | BMD |
| A randomized, double-blind study to evaluate safety and efficacy of transitioning therapy from alendronate to denosumab (AMG 162) in postmenopausal women with low BMD | phase 3 | 500 | BMD |
| A randomized, double-blind study to evaluate AMG 162 in the prevention of postmenopausal osteoporosis | phase 3 | 300 | BMD |
| An open-label, single arm extension study to evaluate the long-term safety of denosumab administration in postmenopausal women with low BMD | Phase 3 | - | Safety |
| Bone metastases/multiple myeloma | |||
| A study of the biological RANKL inhibitor denosumab in subjects with multiple myeloma or bone metastases from breast cancer [13] | phase 1 | 54 | Pharmacokinetics and pharmacodynamics |
| Randomized, active-controlled study of denosumab (AMG162) in breast cancer patients with bone metastasis previously treated with intravenous bisphosphonates [16] | phase 2 | 255 | Urine NTX |
| A randomized trial of denosumab (AMG 162) versus intravenous bisphosphonates in cancer patients with bone metastases on established IV BP and evidence of elevated bone resorption [15] | phase 2 | 135 | Urine NTX |
| An open-label, multicenter, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma | phase 2 | 100 | Complete response/partial response |
| An open-label, multicenter, phase 2 safety and efficacy study of denosumab (AMG 162) in subjects with recurrent or unresectable giant cell tumor (GCT) of bone | phase 2 | 25 | Response rate based on imaging or tissue samples |
| A randomized, double-blind multicenter study of denosumab compared with zoledronic acid in the treatment of bone metastases in men with hormone-refractory prostate cancer | phase 3 | 1,700 | Skeletal related events |
| A randomized, double-blind, multicenter study of denosumab compared with zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer | phase 3 | 1,400 | Skeletal related events |
| Double-blind study of denosumab compared with zoledronic acid in the treatment of bone metastases in subjects with advanced cancer (excluding breast and prostate cancer) or multiple myeloma | phase 3 | 1,700 | Skeletal related events |
| A randomized, double-blind, placebo-controlled, multicenter phase 3 study of denosumab on prolonging bone metastasis-free survival in men with hormone refractory prostate cancer | phase 3 | 1,400 | Time to first occurence of bone metastasis or death from any cause |
| Treatment-induced bone loss | |||
| A randomized, double-blind, placebo-controlled study to evaluate AMG 162 in the treatment of bone loss in patients undergoing androgen deprivation therapy for nonmetastatic prostate cancer | phase 3 | 1,400 | BMD |
| A randomized, double-blind, placebo-controlled study to evaluate AMG 162 in the treatment of bone loss in patients undergoing aromatase inhibitor therapy for nonmetastatic breast cancer | phase 3 | 208 | BMD |
| Rheumatoid arthritis | |||
| A randomized, double-blind, placebo-controlled, multidose phase 2 study to determine the efficacy, safety, and tolerability of AMG 162 in the treatment of rheumatoid arthritis [17] | phase 2 | 227 | Bone erosions |
CT, computed tomography; mAb, monoclonal antibody; NTX, N-telopeptide; RANKL, receptor activator of nuclear factor-κB ligand.