Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
zoledronic acid · 1 trial · 1 indication
Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.
| Arm | Type | Description |
|---|---|---|
| zoledronic acid | ACTIVE_COMPARATOR | - |
| denosumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| zoledronic acid | DRUG | Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC |
| denosumab | BIOLOGICAL | Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes |
Inclusion Criteria: * Men \>/= 18 years of age with histologically confirmed prostate cancer * Radiographic evidence of at least one bone metastasis * Failure of at least one hormonal therapy as evidenced by a rising PSA * Serum testosterone level of \<50 ng/dL * ECOG PS 0, 1, or 2 * Adequate organ...
Zoledronic acid is used for bone metastases, specifically in men with hormone-refractory prostate cancer. It is being studied as an active comparator in a Phase 3 clinical trial. The drug is a small molecule developed by Amgen Inc. and is currently in Phase 3 clinical development.
Zoledronic acid is a bisphosphonate that inhibits bone resorption by targeting osteoclast activity. It works by binding to bone mineral and being taken up by osteoclasts, leading to their apoptosis. This reduces the release of calcium from bone and helps prevent skeletal complications in patients with bone metastases.
Zoledronic acid is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug for the treatment of bone metastases in patients with hormone-refractory prostate cancer.
Zoledronic acid is in Phase 3 clinical development. It is being studied in a completed Phase 3 trial (NCT00321620) that enrolled 1904 male patients with bone metastases from hormone-refractory prostate cancer. The drug is investigational and not yet approved for this indication.
Zoledronic acid is associated with one completed Phase 3 clinical trial, NCT00321620, titled 'Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer.' This randomized, double-blind, active-controlled trial enrolled 1904 male patients aged 18 years and older.
No, zoledronic acid is not the same as denosumab. Zoledronic acid is a bisphosphonate that inhibits bone resorption, while denosumab is a monoclonal antibody targeting RANKL. In the clinical trial NCT00321620, zoledronic acid was used as an active comparator against denosumab to treat bone metastases in prostate cancer patients.