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This research will examine the effectiveness of calcitriol in treating bone loss in women who are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected to take part in this study. The investigators don't know if bone loss in breast cancer survivors should be treated differently than bone loss in other women.
The calcitriol intervention is aimed at reducing fracture risk by maintaining proper bone density. Calcitriol is efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on breast cancer patients. In addition, calcitriol may be effective in reducing tumor proliferation and angiogenesis, while increasing tumor apoptosis. Each of those factors could have beneficial effects on breast cancer outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcitriol | Experimental | Calcitriol 45mcg/week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitriol | Drug | In pill form, 45 micrograms once a week for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Bone Resorption: NTX (N-terminal Telopeptide) | Scale score for NTX (N-terminal telopeptide) minimum value = 4.2 nmol BCE; maximum value = 3688 nmol BCE Higher scale score for NTX indicates worse outcome. | baseline to 12 weeks |
| Mean Change in Bone Formation: BAP (Bone-specific Alkaline Phosphatase) | Scale score for BAP (Bone-specific alkaline phosphatase) minimum value = 7 mcg/L; maximum value = 329 mcg/L Higher scale score for BAP indicates worse outcome. | baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke J Peppone, PhD | University of Rochester | Principal Investigator |
| Joseph J Guido, MS | Univ of Rochester | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcitriol | Calcitriol 45mcg/week Calcitriol: In pill form, 45 micrograms once a week for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcitriol | Calcitriol 45mcg/week Calcitriol: In pill form, 45 micrograms once a week for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Bone Resorption: NTX (N-terminal Telopeptide) | Scale score for NTX (N-terminal telopeptide) minimum value = 4.2 nmol BCE; maximum value = 3688 nmol BCE Higher scale score for NTX indicates worse outcome. | Posted | Mean | Standard Deviation | nmol | baseline to 12 weeks |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcitriol | Calcitriol 45mcg/week Calcitriol: In pill form, 45 micrograms once a week for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luke J Peppone, PhD, MPH | University of Rochester | 585-275-7827 | Luke_Peppone@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2014 | Jan 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Present Family Income | Count of Participants | Participants |
|
| During the past 5 years did you regularly take a Multivitamin? | Count of Participants | Participants |
|
| During the past 5 years did you regularly take Vitamin D? | Count of Participants | Participants |
|
| During the past 5 years did you regularly take a Calcium Supplement | Count of Participants | Participants |
|
| Do you know or have you ever smoked 100 cigarettes in your lifetime? | Count of Participants | Participants |
|
|
| Primary | Mean Change in Bone Formation: BAP (Bone-specific Alkaline Phosphatase) | Scale score for BAP (Bone-specific alkaline phosphatase) minimum value = 7 mcg/L; maximum value = 329 mcg/L Higher scale score for BAP indicates worse outcome. | Posted | Mean | Standard Deviation | mcg/L | baseline to 12 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |