Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01920568 | A Study to Compare Denosumab With Zoledronic Acid in Subjects With Bone Metastases From Solid Tumors | PHASE3 | COMPLETED | 487 | — | — | Aug 1, 2013 | Apr 1, 2016 | Jan 16, 2017 | 25 | China, Singapore +1 |
uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment (trt). uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Primary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in par. of Asian ancestry with bone metastases from solid tumors. BL value is the most recent, non-missing value prior to or on the 1st study trt dose date. Chg from BL is the value at Wk13 minus BL value. Percent chg from BL is the chg from BL / BL value \* 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.
| Arm | Type | Description |
|---|---|---|
| Denosumab 120 mg | EXPERIMENTAL | Subjects will be administered with Denosumab 120 mg subcutaneous (SC) injection for a maximum of 13 doses and placebo IV infusion over \>=15 minutes once every 4 weeks. |
| Zoledronic acid 4 mg | EXPERIMENTAL | Subjects will be administered with Zoledronic acid 4 mg IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo SC once every 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Denosumab 70 mg/mL | BIOLOGICAL | Denosumab will be given as a SC injection of 120 mg by administering a 1.7 mL volume in a single injection |
| Zoledronic acid 4 mg | DRUG | Zoledronic acid 4 mg (or equivalent clearance-adjusted dose in subjects with baseline creatinine clearance \<=60 ml/min) will be diluted in either 0.9% sodium chloride or 5% dextrose injection and administered IV. |
| Placebo IV | DRUG | The placebo will consist of 1.7 mL 0.9% w/v sodium chloride |
| Placebo SC | DRUG | The placebo will consist of either 0.9% w/v sodium chloride or 5% dextrose injection |
| Calcium supplement | DIETARY_SUPPLEMENT | Subjects are strongly recommended to take daily supplements of at least 500 mg calcium from the day of consent and until completion of the Week 73 follow-up visit. |
| Vitamin D supplement | DIETARY_SUPPLEMENT | Subjects are strongly recommended to take daily supplements of at least 400 IU of vitamin D from the day of consent and until completion of the Week 73 follow-up visit. |
Inclusion Criteria: * Subject understands the nature and purpose of this study and the study procedures, which have been explained by the Investigator or delegate, and subject has signed the written informed consent for the overall study. The subject must sign a separate written informed consent to...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 23 | NA | Undisclosed |
| Stryker Corporation | SYK | 4 | — | Undisclosed |
| Johnson & Johnson | JNJ | 1 | NA | Undisclosed |
| Orthofix Medical, Inc. | OFIX | 1 | — | Undisclosed |
| Cooper Companies, Inc. | COO | 1 | — | Undisclosed |