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

University of Arkansas

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01431872

131471

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

17 participants in 1 patient group

Post menopausal breast cancer patients