Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT00766532
Eligibility Criteria:
Inclusion Criteria:
* Women at least 5 years past menopause, defined as date of last menses or bilateral oophorectomy
* Newly diagnosed breast cancer and starting an AI as initial adjuvant therapy
Exclusion Criteria
* Recent, current or planned chemotherapy for breast cancer, as this may have independent effects on intestinal health, calcium homeostasis and bone turnover
* Allergy or intolerance to orange juice, as one isotope is given with orange juice
* Current use of over-the-counter or prescription antacids, as they may influence Ca-Ab
* Intestinal conditions associated with malabsorption or low gastric acid levels including Crohn's disease, ulcerative colitis, pernicious anemia, bacterial overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month
* Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR \<30 cc/minute
* Use of medications known to interfere with calcium or vitamin D metabolism, including oral steroids or anticonvulsants
* Significant lymphedema precluding adequate intravenous access
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00766532
Study Brief:
Protocol Section:
NCT00766532