---
title: Systemic Dickkopf-related Protein 1 (DKK1)During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors
nct_id: NCT01431872
overall_status: COMPLETED
sponsor: University of Arkansas
study_type: OBSERVATIONAL
primary_condition: Breast Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01431872.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01431872"
ct_last_update_post_date: 2015-11-04
last_seen_at: "2026-05-12T07:12:57.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Systemic Dickkopf-related Protein 1 (DKK1)During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors

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

**NCT ID:** [NCT01431872](https://clinicaltrials.gov/study/NCT01431872)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 17
- **Lead Sponsor:** University of Arkansas
- **Conditions:** Breast Cancer
- **Start Date:** 2011-04
- **Completion Date:** 2015-08
- **CT.gov Last Update:** 2015-11-04

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Post menopausal breast cancer patients**

## 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.

## Locations (1)

- University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of arkansas for medical sciences|little rock|arkansas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01431872.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01431872*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*