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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
May 2007
NCT00089661Uploaded 09-26-2016
Available for Download
PDS UID: Breast_Amgen_2004_153
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
Provider Information
Provider Data DescriptionThe primary objective of this study was to determine whether denosumab compared with placebo preserved lumbar spine bone mineral density (BMD) during aromatase inhibitor therapy in subjects with nonmetastatic breast cancer after 12 months. The secondary objectives were to assess the effect of denosumab compared with placebo on BMD of the total hip and femoral neck and the safety and pharmacokinetics of denosumab in subjects with nonmetastatic breast cancer undergoing aromatase inhibitor therapy. The exploratory objectives were to evaluate the following parameters during the 24-month treatment period: BMD of the distal 1/3 radius (left forearm) and total body; bone resorption and formation, as measured by serum type 1 Ctelopeptide (CTX1) and procollagen Type 1 N-terminal peptide (P1NP); the effect of denosumab compared with placebo on vertebral and nonvertebral fracture incidence; and overall survival at month 24.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset252
# of Patients Control104
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/1rwh-ak32
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.
ConditionsBreast Cancer
Low Bone Mineral Density
Osteopenia
Intervention TypeDrug: Placebo
Drug: AMG 162 / Denosumab
Drug(s)Drug: AMG 162 / Denosumab
Drug: Placebo
Total Enrolled252
RandomizationRandomized
Blinding MethodTriple
Arms InterventionAMG 162 / Denosumab - Experimental
Placebo - Placebo Comparator
Secondary IDN/A
PubMed (PMID)19308727
18725648
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOL20040135 Protocol Amend 3 REDACTED.pdf
CRFAmgen 20040135 CRF REDACTED.pdf
DATA DICTIONARYAmgen 20040135 DDT.pdf
DATA (COMPARATOR ARM)Amgen 20040135 SAS datasets.zip
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