Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Lung (Non-Small Cell), Pancreatic, Melanoma, Ovarian, Neuroendocrine Tumors, Esophageal, Kidney, Uterine Cervix, Colorectal, Lung (Small Cell), Lymphoma (Non-Hodgkins), Multiple Myeloma, Head-Neck, Soft Tissue Sarcoma, Bladder, and Gastric

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

Unique Data Set IDMultiple_Amgen_2006_156
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients1779Comparator (Control) Arm Enrolled Patients702RandomizationYesClinicalTrial.gov IDNCT00330759ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00330759?term=20050244&rank=2
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeBest Supportive CareData Set TypeADS

Clinical Trial Title

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

Trial Summary and Conditions

This is an international phase 3, randomized, double-blind,active controlled study comparing denosumab with zoledronic acid in the treatment of bone metastases in subjects with advanced cancer or multiple myeloma. Approximately 1690 subjects will be randomized in a 1:1 ratio to receive either denosumab, administered at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W), or zoledronic acid, administered IV at a dose of 4 mg (equivalent creatinine clearance-adjusted dose in subjects with baseline creatinine clearance . 60 mL/min) as a single, minimum 15-minute infusion Q4W in a blinded manner. Randomization will be stratified by tumor type (non-small cell lung cancer or multiple myeloma or other), previous SRE (Yes or No), systemic anti-cancer therapy (eg, chemotherapy, biologic therapy or hormonal therapy; Yes or No) and region (Japan or other countries). Within each stratum subjects will be randomized using an equal allocation ratio of 1:1. Stratification for tumor type will be bounded for this study limiting the enrollment to the non-small cell lung cancer stratum to 60% of the total study population and the multiple myeloma stratum to 10%. Each subject will receive either an SC injection of denosumab and an IV infusion of zoledronic acid placebo Q4W, or an SC injection of denosumab placebo and an IV infusion of zoledronic acid Q4W until approximately 745 subjects have experienced an on-study SRE and the primary efficacy and safety analysis is completed.

Data Summary

Control arm data including demographics, disease characteristics, safety and efficacy

Study Objectives

The primary objective of this study was to determine if denosumab is noninferior to zoledronic acid with respect to the first on-study SRE (pathologic fracture, radiation therapy to bone [including the use of radioisotopes], surgery to bone, or spinal cord compression) in subjects with advanced cancer and bone metastases (or lytic bone lesions from multiple myeloma). The secondary objectives were to determine if denosumab is superior to zoledronic acid with respect to first on-study SRE, to determine if denosumab is superior to zoledronic acid with respect to the first-and-subsequent on-study SRE (multiple event analysis), and to assess the safety and tolerability of denosumab compared with zoledronic acid.

Outcome Measures

The primary objective of this study was to determine if denosumab is noninferior to zoledronic acid with respect to the first on-study SRE (pathologic fracture, radiation therapy to bone [including the use of radioisotopes], surgery to bone, or spinal cord compression) in subjects with advanced cancer and bone metastases (or lytic bone lesions from multiple myeloma). The secondary objectives were to determine if denosumab is superior to zoledronic acid with respect to first on-study SRE, to determine if denosumab is superior to zoledronic acid with respect to the first-and-subsequent on-study SRE (multiple event analysis), and to assess the safety and tolerability of denosumab compared with zoledronic acid.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 20050244 Protocol Amend 1 REDACTED.pdf

CRF: Amgen 20050244 CRF REDACTED.pdf

DATA DICTIONARY: Amgen 20050244 DDT.pdf

DATA (COMPARATOR ARM): Amgen 20050244 SAS datasets.zip