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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
2012-07
NCT00079001Uploaded 07-07-2018
Access via NCI by Request
PDS UID: nci-data-373
A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone
Provider Information
Provider Data DescriptionNCT00079001-D3-Dataset.csv (ae) is one of 3 datasets that contain the data published in the analyses of PubMed ID 24590644. This dataset contains information that will allow you to reproduce the toxicity reported.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases. PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.
ConditionsMetastatic Cancer
Prostate Cancer
Intervention TypeDrug: zoledronic acid
Other: placebo
Drug: androgen deprivation therapy
Drug: GnRH agonist
Dietary Supplement: Calcium supplement
Dietary Supplement: Vitamin D
Drug(s)Drug: zoledronic acid
Drug: androgen deprivation therapy
Drug: GnRH agonist
Total Enrolled645
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionZoledronic acid + androgen deprivation therapy - Experimental
Placebo + androgen deprivation therapy - Active Comparator
Secondary IDU10CA031946
PubMed (PMID)24590644
33270906
Collaborator(s)National Cancer Institute (NCI)
SWOG Cancer Research Network
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Novartis Pharmaceuticals
Region(s)United States
Canada
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00079001-D3
Data DictionaryNCT00079001-D3-Data-Dictionary.pdf
DATANCT00079001-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00079001-D2
Data DictionaryNCT00079001-D2-Data-Dictionary.pdf
DATANCT00079001-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00079001-D1
Data DictionaryNCT00079001-D1-Data-Dictionary.pdf
DATANCT00079001-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT00079001-D4
Data DictionaryNCT00079001-D4-Data-Dictionary_1.pdf
DATANCT00079001-D4-Dataset_2.csv
OTHERREADME.pdf
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