Trials / Completed
CompletedNCT00089661
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 252 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months |
| DRUG | AMG 162 / Denosumab | 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2007-05-11
- Completion
- 2009-05-27
- First posted
- 2004-08-11
- Last updated
- 2018-10-17
- Results posted
- 2010-01-26
Source: ClinicalTrials.gov record NCT00089661. Inclusion in this directory is not an endorsement.