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Prostate

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

Unique Data Set IDProstat_AmgenI_2006_121
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients1904Comparator (Control) Arm Enrolled Patients756RandomizationYesClinicalTrial.gov IDNCT00321620 ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/results/NCT00321620?term=denosumab+prostate+cancer&rank=5
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeBiologicsData 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 Men with Hormone-Refractory Prostate Cancer

Trial Summary and Conditions

Bone complications associated with cancer arise from increased bone resorption and include bone pain, pathologic bone fractures, nerve compression, and hypercalcemia. Accumulating evidence suggests that most pathologic bone resorption relies on the RANK/RANKL pathway, which regulates the differentiation, survival, and activation of osteoclasts. Another key component of RANK/RANKL pathway is OPG, an endogenous decoy receptor that binds and neutralizes RANKL. The antiresorptive property of OPG has been demonstrated in murine models of hypercalcemia of malignancy and metastatic bone destruction. According to recent findings, it appears that maximum anti-resorptive effects due to RANKL-RANK pathway inhibition are more pronounced than those due to bisphosphonates.

Data Summary

These datasets are analysis datasets that bear some resemblance to CDISC ADaM standards. These datasets has been subsetted to include data from only the comparator arm of this clinical trial.

Study Objectives

PRIMARY 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

Outcome Measures

Outcomes documented in the protocol

Available Downloads:

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

PROTOCOL: Amgen 20050103 Protocol.pdf

CRF: Amgen 20050103 CRF.pdf

DATA DICTIONARY: Amgen 20050103 DDT.pdf

DATA (COMPARATOR ARM): Amgen 20050103 SAS datasets.zip