Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Musculoskeletal Diseases

Blood and Lymph Conditions

Prostatic Neoplasms

Neoplasm Metastasis

Fractures, Bone

Bone Neoplasms

Bone Marrow Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Hormones

Zoledronic Acid

Denosumab

Diphosphonates

Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC

zoledronic acid

Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes

denosumab

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer

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.

Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.

Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.

This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.

Amgen

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

One subject who was randomized to zoledronic acid and received denosumab as the 1st investigational product was analyzed on the denosumab arm for safety analyses.

Zoledronic Acid 4 mg Q4W

Denosumab 120 mg Q4W

Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks

Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks

Total

Age, Continuous

Sex: Female, Male

White or Caucasian

Black or African American

Hispanic or Latino

Asian

Native Hawaiian or Other Pacific Islander

Other

Race/Ethnicity, Customized

PSA level < 10 ng/mL

PSA level ≥ 10 ng/mL

Prostate-Specific Antigen (PSA) Stratification Factor

Previous Skeletal-Related Event (SRE) Stratification Factor

Defined as within 6 weeks before randomization

Current Prostate Cancer Chemotherapy Stratification Factor

Study Director

Full Analysis Set, composed of all randomized participants

Time to the First On-Study SRE (Non-inferiority)

Time to the First On-Study SRE (Superiority)

Time to the First-And-Subsequent On-Study SRE

Overall Study

Spots Global Cancer Trial Database for Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial