Table 1.
Summary of the main clinical trials in oncology assessing anti-RANKL therapies.
| Clinical trials drug assessed | Cancer | Number of patients included | Doses | References |
|---|---|---|---|---|
| Phase I OPG recombinant | Bone metastases (Breast) | 26 | s.c. 0.1–3 mg/kg | [91] |
| Myeloma | 28 | |||
| Phase I, Denosumab | Bone metastases (Breast) | 29 | Denosumab s.c. 0.1–3 mg/Kg Pamidronate 90m g i.v. | [95] |
| Myeloma | 25 | |||
| Randomized, double blind | Bone metastases (excluding breast, prostate and myeloma) | 886 | Denosumab s.c. 120 mg monthly Zoledronate i.v. 4 mg monthly | [96] |
| Denosumab versus zoledronate | 890 | |||
| Randomized, double blind | Bone metastases (Breast) | 1026 | Denosumab s.c. 120 mg monthly Zoledronate i.v. 4 mg monthly | [97] |
| Denosumab versus zoledronate | 1020 | |||
| Phase II, Denosumab with and without bisphosphonate exposure | Bone metastases | 366 | Denosumab s.c. 60 or 180 mg every 12 weeks Denosumab s.c. 30, 120, or 180 mg every 4 weeks | [98], [99], [100] |
| Denosumab vs placebo and adjuvant aromatase inhibitors | Non-metastatic breast cancer | 127 (treated) 125 (placebo) | Denosumab s.c. 60 mg every 6 weeks | [101], [102] |
| Phase II, randomized trial Denosumab after i.v. bisphosphonates | Bone metastases (prostate, breast cancers and other neoplasms) | 111 | Denosumab s.c. 180 mg every 4 or 12 weeks | [103] |
| Phase II Denosumab | Myeloma | 96 | Denosumab s.c.120 mg on days 1, 8, and 15 (loading doses) of cycle 1 (28 day), and then on study day 29 (day 1 of cycle 2) and on day 1 of every cycle (28 day) thereafter | [104] |
| Phase II, Randomized Denosumad after i.v. bisphosphonates | Bone metastases (Prostate) | 111 | Denosumab s.c. 180 mg every 4 or 12 weeks | [105] |
| Double-blind study Denosumad and androgen-deprivation | Prostate cancer | 734 per group | Denosumab s.c. 60 mg every 6 months | [106] |
| Double-blind study Denosumab and androgen-deprivation | Prostate cancer | 734 per group | Denosumab s.c. 60 mg every 6 months | [107] |
| Phase III Denosumab in castration-resistant patients | Prostate cancer | 716 per group | Denosumab s.c. 120 mg every 4 weeks | [108] |
| Phase III, Denosumab versus zoledronate in castration-resistant patients | Prostate cancer | 950 per group | Denosumab s.c. 120 mg or zoledronate 4 mg i.v. every 4 weeks | [109] |
| Phase II Denosumab | Giant cell tumours of bone | 37 | Denosumab s.c. 120 mg monthly | [110] |