Systemic Dickkopf-related Protein 1 (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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72120, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Sep 12, 2011
Registry last updated: Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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