Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Wounds and Injuries

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Nervous System Diseases

Musculoskeletal Diseases

Rare Diseases

Prostatic Neoplasms

Fractures, Bone

Neoplasm Metastasis

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Spinal Cord Compression

Bone Neoplasms

Bone Marrow Diseases

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Neoplastic Processes

Bone Diseases

Lymphosarcoma

Bone Density Conservation Agents

All Drugs and Chemicals

Zoledronic Acid

Denosumab

Diphosphonates

denosumab placebo with active zoledronic acid

active denosumab with zoledronic acid placebo

120 milligrams by subcutaneous injection every 4 weeks

4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma.

Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.

Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.

Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, 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.

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 by subcutaneous injection 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

Japanese

American Indian or Alaska Native

Other

Race/Ethnicity, Customized

Multiple myeloma

Non-small cell lung cancer

Tumor Type Stratification Factor

Previous Skeletal-Related Event Stratification Factor

Systematic Anti-Cancer Therapy Stratification Factor

Study Director

Full Analysis Set, composed of all randomized participants.

Time to the First On-Study Skeletal-Related Event (Non-Inferiority)

Time to First On-Study Skeletal-Related Event (Superiority)

Full Analysis Set, composed of all randomized participants

Time to the First-and-Subsequent On-Study Skeletal-Related Event

Overall Study

Spots Global Cancer Trial Database for Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial