A Phase 4 interventional study of Aromatase Inhibitor in Breast Cancer, Osteoporosis and Osteopenia, sponsored by University of Wisconsin, Madison. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2012-09-14.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Diagnostic
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 12 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
aromatase inhibitor therapy for six weeks
Drug: Aromatase Inhibitor
Any aromatase inhibitor started as initial adjuvant therapy
Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy
intestinal calcium absorption
Time frame: baseline and 6 weeks later
Postmenopausal women with early stage breast cancer and planning to start aromatase inhibitor therapy.
| Milestone | Arm Title- Aromatase Inhibitor Therapy |
|---|---|
| Started | 12 |
| Completed | 10 |
| Not completed | 2 |
| Withdrew: Protocol violation | 2 |
intestinal calcium absorption
| percent calcium absorption | Aromatase Inhibitor Therapy |
|---|---|
| Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy | 16 ± 6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Group 1 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 6 |
| Age Continuous(years) | Group 1 |
|---|---|
| Mean | 66 ± 7 |
| Sex: Female, Male(Participants) | Group 1 |
|---|---|
| Female | 12 |
| Male | 0 |
| Region of Enrollment(participants) | Group 1 |
|---|---|
| United States | 12 |
No study locations are listed for this record.
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison