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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431872
• Other study ID #: 131471
• Status: Completed
• Phase: N/A
• First received: September 8, 2011
• Last updated: November 3, 2015
• Start date: April 2011
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No