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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Estrogen level suppresses DKK1

Outcome Description:

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.

Outcome Time Frame:

26 weeks

Safety Issue:

No

Principal Investigator

Laura Hutchins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Institutional Review Board

Study ID:

131471

NCT ID:

NCT01431872

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Breast Cancer
  • Aromatase Inhibitors
  • Breast Neoplasms

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205