Breast CancerPhase 4NCT00766532
Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?
A Phase 4 study testing Aromatase Inhibitor in people with Breast Cancer and Osteoporosis, run by University of Wisconsin, Madison.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Osteoporosis, Osteopenia
- What is being tested?
- Aromatase Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Being tested
- Aromatase Inhibitor
- Medical subject headings
- Breast Neoplasms, Osteoporosis, Bone Diseases, Metabolic, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatase InhibitorDrug
Any aromatase inhibitor started as initial adjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| aromatase inhibitor therapy | Experimental | aromatase inhibitor therapy for six weeks Receives: Drug: Aromatase Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy
intestinal calcium absorption
Measured: baseline and 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen E Hansen, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766532
- Sponsor's protocol ID
- H-2008-0144
- Status last verified
- Sep 2012
- First submitted
- 2 Oct 2008
- Last updated
- 14 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22350731
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?
- ClinicalTrials.gov ID
- NCT00766532
- Acronym / sponsor ID
- H-2008-0144
- Conditions
- Breast Cancer, Osteoporosis, Osteopenia, Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Oct 2008 (estimated)
- Results
- Posted 14 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aromatase inhibitor therapy | Experimental | Drug: Aromatase Inhibitoraromatase inhibitor therapy for six weeks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatase InhibitorAny aromatase inhibitor started as initial adjuvant therapy | Drug | aromatase inhibitor therapy |
Primary outcome
Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy
Time frame: baseline and 6 weeks later
intestinal calcium absorption
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22350731Tevaarwerk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen E Hansen, MD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aromatase Inhibitor in people with Breast Cancer and Osteoporosis, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy (time frame: baseline and 6 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00766532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2012.