Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?

NCT00766532 | Completed Phase 4 Results DMC

• 1 other identifier: H-2008-0144
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption? Study Design: Postmenopausal women with early stage breast cancer initiating aromatase inhibitor adjuvant therapy will participate in this two-month study. The primary study outcome is the change in intestinal calcium absorption following such therapy. Secondary outcomes are the changes in bone resorption markers and musculoskeletal signs and symptoms after initiation of therapy. We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo two calcium absorption studies. The first study will determine their baseline calcium absorption, and the second study will occur after taking an aromatase inhibitor daily for at least 6 weeks. Women will present to the research unit in the early morning and receive an oral and intravenous stable calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During each inpatient stay, we will assess musculoskeletal symptoms by questionnaire and joint examination. Each woman will complete a four-day diet diary twice during the study.

Conditions

Breast Cancer; Osteoporosis; Osteopenia; Fracture

Outcome Measures

Primary Outcomes (1)

• Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy

  intestinal calcium absorption

  baseline and 6 weeks later

Study Arms (1)

aromatase inhibitor therapy

EXPERIMENTAL

aromatase inhibitor therapy for six weeks

Drug: Aromatase Inhibitor

Interventions

Aromatase Inhibitor DRUG

Any aromatase inhibitor started as initial adjuvant therapy

aromatase inhibitor therapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Related Publications (1)

• Tevaarwerk A, Burkard ME, Wisinski KB, Shafer MM, Davis LA, Gogineni J, Crone E, Hansen KE. Aromatase inhibitors and calcium absorption in early stage breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):245-51. doi: 10.1007/s10549-012-1982-z. Epub 2012 Feb 18.

  PMID: 22350731 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis; Bone Diseases, Metabolic; Fractures, Bone

Interventions

Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Results Point of Contact

• Title: Dr. Karen Hansen
• Organization: University of Wisconsin

keh@medicine.wisc.edu

608-263-0517

Study Officials

• Karen E Hansen, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 6, 2008
• Study Start: January 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 14, 2012
• Results First Posted: September 14, 2012

Record last verified: 2012-09