Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Prostate

A Randomized, Double-blind, Placebo-controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-deprivation Therapy for Nonmetastatic Prostate Cancer

Unique Data Set IDProstat_Amgen_2004_154
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients1468Comparator (Control) Arm Enrolled Patients584RandomizationYesClinicalTrial.gov IDNCT00089674ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00089674?term=20040138&rank=2
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 Androgen-deprivation Therapy for Nonmetastatic Prostate Cancer

Trial Summary and Conditions

This was an international, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of denosumab in men undergoing ADT for nonmetastatic prostate cancer. Subjects were randomized in a 1:1 allocation to receive either 60 mg denosumab or placebo subcutaneously once every 6 months for 30 months (ie, the 36-month treatment period). Randomization was stratified by age group (< 70 years vs ? 70 years) and duration of ADT with GnRH agonist or orchiectomy at study entry (? 6 months vs > 6 months). Eligible subjects were men with histologically-confirmed prostate cancer and were ? 70 years of age, or were < 70 years of age with either low baseline BMD (T-score at the lumbar spine, total hip, or femoral neck < -1.0) or history of an osteoporotic fracture.

Data Summary

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

Study Objectives

The primary objective of this study was to determine the treatment effect of denosumab compared with placebo on lumbar spine BMD at month 24 in men with nonmetastatic prostate cancer undergoing androgen deprivation therapy (ADT). The secondary objectives were to determine the treatment effect of denosumab compared with placebo on percentage change of femoral neck BMD and total hip BMD from baseline to month 24; percentage change of lumbar spine BMD, femoral neck BMD, and total hip BMD from baseline to month 36; subject incidence of any fracture (ie, osteoporotic fracture at any skeletal site including vertebral fractures, but excluding skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges) and subject incidence of new vertebral fracture over the 36-month treatment period; time to first clinical fracture over the 36-month treatment period; and subject incidence of any fracture over the 24-month treatment period.

Outcome Measures

The primary objective of this study was to determine the treatment effect of denosumab compared with placebo on lumbar spine BMD at month 24 in men with nonmetastatic prostate cancer undergoing androgen deprivation therapy (ADT). The secondary objectives were to determine the treatment effect of denosumab compared with placebo on percentage change of femoral neck BMD and total hip BMD from baseline to month 24; percentage change of lumbar spine BMD, femoral neck BMD, and total hip BMD from baseline to month 36; subject incidence of any fracture (ie, osteoporotic fracture at any skeletal site including vertebral fractures, but excluding skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges) and subject incidence of new vertebral fracture over the 36-month treatment period; time to first clinical fracture over the 36-month treatment period; and subject incidence of any fracture over the 24-month treatment period.

Available Downloads:

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

PROTOCOL: 20040138 Protocol Amend 5 REDACTED.pdf

CRF: Amgen 20040138 CRF REDACTED.pdf

DATA DICTIONARY: Amgen 20040138 DDT.pdf

DATA (COMPARATOR ARM): Amgen 20040138 SAS datasets.zip