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Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?


Phase 4
N/A
N/A
Not Enrolling
Female
Breast Cancer, Osteoporosis, Osteopenia, Fracture

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Trial Information

Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy

Outcome Description:

intestinal calcium absorption

Outcome Time Frame:

baseline and 6 weeks later

Safety Issue:

Yes

Principal Investigator

Karen E Hansen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin School of Medicine and Public Health

Authority:

United States: Institutional Review Board

Study ID:

H-2008-0144

NCT ID:

NCT00766532

Start Date:

January 2009

Completion Date:

October 2010

Related Keywords:

  • Breast Cancer
  • Osteoporosis
  • Osteopenia
  • Fracture
  • Breast Neoplasms
  • Fractures, Bone
  • Bone Diseases, Metabolic
  • Osteoporosis

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