Systemic Dickkopf-related Protein 1 (DKK1)During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors
|ClinicalTrials.gov Identifier: NCT01431872|
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : November 4, 2015
The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to peak, then decrease gradually as estrogens reach a new lower, but steady level. The investigators also believe that the peak in DKK1 will initiated a wave of stem cell diversion from the osteoblastogenic pathway to the adipogenic pathway.
The investigators will conduct a longitudinal cohort study of post menopausal women with hormone-responsive breast cancer that will be treated AIs. The study will observe anthromorphic and serum marker changes during the first year of their treatment.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||17 participants|
|Official Title:||Systemic DKK1 During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
|Post menopausal breast cancer patients|
- Estrogen level suppresses DKK1 [ Time Frame: 26 weeks ]With the start of AI treatment, estrogen levels will decline to almost undetectable levels. We believe this decrease in estrogen will lift suppression of DKK1 and allow its expression to peak during the 1st month of treatment, and decline more slowly thereafter. During the first 26 weeks of treatment, we expect levels of CTx to rise, PTH to fall, and P1NP to show no change, findings that would be consistent with Heshmati's study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431872
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72120|
|Principal Investigator:||Laura Hutchins, MD||University of Arkansas|