AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Placebo; Drug: AMG 162

• Registration Number: NCT00089674
• Lead Sponsor: Amgen

Brief Summary

This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-01
• Study First Submitted: 2004-08-09
• Study First Submitted QC: 2004-08-10
• Study First Posted: 2004-08-11
• Primary Completion: 2008-05-16
• Disposition First Submitted: 2009-11-23
• Disposition First Submitted QC: 2009-11-23
• Disposition First Posted: 2009-11-25
• Study Completion: 2010-05-11
• Results First Submitted: 2010-07-02
• Results First Submitted QC: 2014-05-08
• Results First Posted: 2014-06-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1468

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
AMG 162	AMG 162	-

Primary Outcome Measures

Name	Time	Method
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24	24 months	Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

Secondary Outcome Measures

Name	Time	Method
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24	24 months	Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.
Number of Participants With a New Vertebral Fracture Through Month 36	36 months	New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 36	36 months	Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.
Number of Participants With Any Fracture Through Month 36	36 months	Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24	24 months	Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36	36 months	Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36	36 months	Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.
Time to First Clinical Fracture Through Month 36	36 months	A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture.
Number of Participants With Any Fracture Through Month 24	24 months	Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.