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Breast

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

Unique Data Set IDBreast_Amgen_2004_153
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients252Comparator (Control) Arm Enrolled Patients104RandomizationYesClinicalTrial.gov IDNCT00089661ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00089661?term=20040135&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeBest Supportive CareData Set TypeADS

Clinical Trial Title

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

Trial Summary and Conditions

This was a multicenter, randomized, double-blind, placebo-controlled study in subjects receiving adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer. Subjects were randomized in a 1:1 allocation to receive either 60 mg denosumab or placebo subcutaneously once every 6 months for 24 months (a total of 4 injections) (ie, the 24-month treatment period). Randomization was stratified by duration of aromatase inhibitor therapy (. 6 months vs > 6 months). Subjects were followed for 24 months after the last dose of investigational product (ie, the 24-month safety follow-up period).

Data Summary

Control arm data including demographics, disease characteristics, safety and efficacy

Study Objectives

The 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.

Outcome Measures

The 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.

Available Downloads:

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

PROTOCOL: 20040135 Protocol Amend 3 REDACTED.pdf

CRF: Amgen 20040135 CRF REDACTED.pdf

DATA DICTIONARY: Amgen 20040135 DDT.pdf

DATA (COMPARATOR ARM): Amgen 20040135 SAS datasets.zip