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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01431872

Enrollment

Registered

2011-09-12

Start date

2011-04-30

Completion date

2015-08-31

Last updated

2015-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Aromatase Inhibitors

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Estrogen level suppresses DKK1	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.

Countries

United States

Outcome results