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

This study is currently recruiting participants.
Verified April 2013 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01431872
First received: September 8, 2011
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systemic DKK1 During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Estrogen level suppresses DKK1 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Post menopausal breast cancer patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431872

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72120
Contact: Cindy Walton     501-686-8274     waltoncynthial@uams.edu    
Principal Investigator: Laura Hutchins, MD            
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Laura Hutchins, MD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01431872     History of Changes
Other Study ID Numbers: 131471
Study First Received: September 8, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Aromatase Inhibitors

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

ClinicalTrials.gov processed this record on May 19, 2013