drugset / Trial / NCT02099461
Effect of Denosumab on Cellular Biomarkers in the Human Breast
RandomizedParallel-groupOpen-labelBasic science
Summary
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
Timeline
- Start
- 2014-04
- Primary completion
- 2014-07
- Completion
- 2014-07
Outcome
Missed primary endpoint
registry No Treatment vs Denosumab 60 mg; p = 0.1343; LS Mean Difference -0.31 (95% CI -0.720 to 0.098); ANCOVA NCT02099461 ↗
registry No Treatment vs Denosumab 120 mg; p = 0.2345; LS Mean Difference -0.24 (95% CI -0.646 to 0.161); ANCOVA NCT02099461 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Subject | Denosumab | Monoclonal antibody | 120 mg | Subcutaneous |
Indications
No indication recorded.