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

Sponsor ID

20040138

Clinicaltrials.gov ID

NCT00089674

EUCTIS ID

N/A

EudraCT ID

N/A

Study Details

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

Additional Study Details

Phase

Phase 3

Product

denosumab

Type

Interventional

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment

1468

Additional Study Details

Protocol Summary

Primary Outcome Measures

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24

Timeframe: 24 months

Secondary Outcome Measures

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24

Timeframe: 24 months

Total Hip Bone Mineral Density Percent Change From Baseline at Month 24

Timeframe: 24 months

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36

Timeframe: 36 months

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36

Timeframe: 36 months

Total Hip Bone Mineral Density Percent Change From Baseline at Month 36

Timeframe: 36 months

Subject Incidence of any fracture through month 36

Timeframe: 36 months

Subject Incidence of New Vertebral Fracture Through Month 36

Timeframe: 36 months

Time to First Clinical Fracture Through Month 36

Timeframe: 36 months

Subject Incidence of Any Fracture Through Month 24

Timeframe: 24 months

Study Documents

Study Synopsis

Available Language(s): English

Download Document(s)

Locations

No locations found.