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Clinical trials investigating the effects of denosumab |
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| Study name or title on http://www.clinicaltrials.gov |
Phase |
n |
Primary end-point |
|
|
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| Osteoporosis |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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CT, computed tomography; mAb, monoclonal antibody; NTX, N-telopeptide; RANKL, receptor activator of nuclear factor-κB ligand. | |||
Schwarz and Ritchlin Arthritis Research & Therapy 2007 9(Suppl 1):S7 doi:10.1186/ar2171 |
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