Phase 3
N=1,468
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00089674 ↗Enrolled (actual)
1,468
Serious AEs
32.6%
Results posted
Jun 2014
Primary outcome: Primary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 — -1; 5.6 Percent Change from Baseline — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AMG 162 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Amgen
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 |
-1; 5.6 | <0.0001 sig |
| SECONDARY Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 |
-1.5; 2.4 | <0.0001 sig |
| SECONDARY Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 |
-2; 2.7 | <0.0001 sig |
| SECONDARY Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 |
-1.2; 6.8 | <0.0001 sig |
| SECONDARY Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 |
-1.8; 3 | <0.0001 sig |
| SECONDARY Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 |
-2.6; 3.2 | <0.0001 sig |
| SECONDARY Number of Participants With Any Fracture Through Month 36 |
53; 38 | 0.1048 |
| SECONDARY Number of Participants With a New Vertebral Fracture Through Month 36 |
26; 10 | 0.0125 sig |
| SECONDARY Time to First Clinical Fracture Through Month 36 |
5.2; 4.7 | 0.7961 |
| SECONDARY Number of Participants With Any Fracture Through Month 24 |
45; 32 | 0.7961 |
Summary
This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.
Eligibility Criteria
Other criteria also apply
Data sourced from ClinicalTrials.gov (NCT00089674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.