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

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ClinicalTrials.gov Identifier: NCT01431872
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

September 8, 2011
September 12, 2011
November 4, 2015
April 2011
August 2015   (Final data collection date for primary outcome measure)
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.
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 therafter. 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.
Complete list of historical versions of study NCT01431872 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Post menopausal breast cancer patients who are planning to be treated with aromatase inhibitors.
Breast Cancer
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Post menopausal breast cancer patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
30
August 2015
August 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01431872
131471
No
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University of Arkansas
University of Arkansas
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Principal Investigator: Laura Hutchins, MD University of Arkansas
University of Arkansas
November 2015