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Table 1 Clinical trials investigating the effects of denosumab

From: Clinical development of anti-RANKL therapy

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
  1. CT, computed tomography; mAb, monoclonal antibody; NTX, N-telopeptide; RANKL, receptor activator of nuclear factor-κB ligand.