AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

Phase 3

Completed

• Conditions: Low Bone Mineral Density; Osteopenia; Breast Cancer
• Interventions: Drug: AMG 162 / Denosumab; Drug: Placebo

• Registration Number: NCT00089661
• Lead Sponsor: Amgen

Brief Summary

The 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-08-09
• Study First Submitted QC: 2004-08-10
• Study First Posted: 2004-08-11
• Study Start: 2004-10-01
• Primary Completion: 2007-05-11
• Study Completion: 2009-05-27
• Disposition First Submitted: 2009-11-19
• Disposition First Submitted QC: 2009-11-19
• Disposition First Posted: 2009-11-23
• Results First Submitted: 2009-12-22
• Results First Submitted QC: 2009-12-22
• Results First Posted: 2010-01-26
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 252

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 162 / Denosumab	AMG 162 / Denosumab	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12	12 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Secondary Outcome Measures

Name	Time	Method
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6	6 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12	12 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 6	6 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12	12 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6	6 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.