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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431872
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : November 4, 2015
Information provided by (Responsible Party):
University of Arkansas

Brief 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.

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Post menopausal breast cancer patients

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Post menopausal breast cancer patients who are planning to be 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01431872

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72120
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Laura Hutchins, MD University of Arkansas

Responsible Party: University of Arkansas Identifier: NCT01431872     History of Changes
Other Study ID Numbers: 131471
First Posted: September 12, 2011    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

Keywords provided by University of Arkansas:
Aromatase Inhibitors

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists