Systemic Dickkopf-related Protein 1 (DKK1)During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors

Systemic DKK1 During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72120
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Post menopausal breast cancer patients who are planning to be treated with aromatase inhibitors.

Description

Inclusion Criteria:

• Post Menopausal Breast cancer patients with planned treatment of aromatase inhibitors.
• 18 years or older

Exclusion Criteria:

• BMI >30 or <18
• Osteoporosis as defined by protocol.
• Subjects currently on bisphosphonate therapy.
• History of primary or secondary hyperparathyroidism
• History of Hypo-or Hyperthyroidism
• History of Vitamin D levels below LLN
• History of creatinine clearance below the EGFR
• History ofLiver function tests above 1.5 times ULN including LDH, SGOT, SGPT, Alkaline phosphatase, and Bilirubin
• History of documented cirrhosis of the liver
• History of chronic heparin use
• History of chronic glucocorticoid therapy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Post menopausal breast cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estrogen level suppresses DKK1	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.	26 weeks

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Laura Hutchins, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 8, 2011
• First Submitted That Met QC Criteria: September 9, 2011
• First Posted (Estimate): September 12, 2011

Study Record Updates

• Last Update Posted (Estimate): November 4, 2015
• Last Update Submitted That Met QC Criteria: November 3, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Aromatase Inhibitors
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 131471