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Type(s) of Cancer
Breast, Multiple Myeloma, Prostate
Study Phase
Phase 3
Study Completion Date
2014-06
NCT00869206Uploaded 07-27-2023
Access via NCI by Request
PDS UID: nci-data-522
A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
Provider Information
Provider Data DescriptionDataset NCT00869206-D1-Dataset.csv (consort) is one of 10 datasets associated with PubMed ID 28030702. This dataset contains information in the Consort Diagram.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies two different schedules of zoledronic acid to compare how well they work in reducing bone-related complications in patients with breast cancer, prostate cancer, or multiple myeloma that has spread to other places in the body and have bone involvement. Bone-related complications are a major cause of morbidity in patients with metastatic prostate cancer, breast cancer, and multiple myeloma. Zoledronic acid may stop the growth of cancer cells in the bone and may help relieve some of the symptoms caused by bone metastases. It is not yet known whether giving zoledronic acid more or less frequently is more effective in treating patients with metastatic cancer that has spread to the bone.
ConditionsBreast Adenocarcinoma
DS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
Metastatic Malignant Neoplasm to the Bone
Pain
Musculoskeletal Complication
Urinary Complications
Intervention TypeDrug: zoledronic acid
Drug(s)Drug: zoledronic acid
Total Enrolled1822
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (zoledronic acid every 4 weeks) - Experimental
Arm II (zoledronic acid every 12 weeks) - Experimental
Secondary IDCDR0000637947
PubMed (PMID)28030702
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00869206-D1
Data DictionaryNCT00869206-D1-Data-Dictionary_1.pdf
DATANCT00869206-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00869206-D2
Data DictionaryNCT00869206-D2-Data-Dictionary_1.pdf
DATANCT00869206-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00869206-D3
Data DictionaryNCT00869206-D3-Data-Dictionary_1.pdf
DATANCT00869206-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00869206-D4
Data DictionaryNCT00869206-D4-Data-Dictionary_1.pdf
DATANCT00869206-D4-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00869206-D5
Data DictionaryNCT00869206-D5-Data-Dictionary_1.pdf
DATANCT00869206-D5-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00869206-D6
Data DictionaryNCT00869206-D6-Data-Dictionary_1.pdf
DATANCT00869206-D6-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00869206-D7
Data DictionaryNCT00869206-D7-Data-Dictionary_1.pdf
DATANCT00869206-D7-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00869206-D8
Data DictionaryNCT00869206-D8-Data-Dictionary_1.pdf
DATANCT00869206-D8-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00869206-D9
Data DictionaryNCT00869206-D9-Data-Dictionary_1.pdf
DATANCT00869206-D9-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00869206-D10
Data DictionaryNCT00869206-D10-Data-Dictionary_1.pdf
DATANCT00869206-D10-Dataset_1.csv
OTHERREADME.pdf
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