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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
October 2009
NCT00321620Uploaded 03-24-2015
Available for Download
PDS UID: Prostat_AmgenI_2006_121
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
Provider Information
Provider Data DescriptionPRIMARY OBJECTIVE To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in subjects with hormone-refractory prostate cancer and bone metastases. SRE is defined as pathological fracture (vertebral or nonvertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. SECONDARY OBJECTIVES - 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 first-and-subsequent on-study SRE (multiple event analysis) - to assess the safety and tolerability of denosumab compared with zoledronic acid
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset1904
# of Patients Control756
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/xa1a-3663
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe 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
ConditionsBone Metastases
Intervention TypeDrug: zoledronic acid
Biological: denosumab
Drug(s)Drug: zoledronic acid
Total Enrolled1904
RandomizationRandomized
Blinding MethodQuadruple
Arms Interventionzoledronic acid - Active Comparator
denosumab - Experimental
Secondary IDN/A
PubMed (PMID)21353695
25425475
25449207
33270906
26335402
26093811
24722180
23975226
22975218
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLAmgen 20050103 Protocol.pdf
CRFAmgen 20050103 CRF.pdf
DATA DICTIONARYAmgen 20050103 DDT.pdf
DATA (COMPARATOR ARM)Amgen 20050103 SAS datasets.zip
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