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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.
This is a pilot, double-blind, randomized, placebo-controlled study with the following aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment Group | Experimental | Patients with baseline 25OH vitamin D level of 10-19 ng/ml.
Patients with baseline 25OH vitamin D level of 20-29 ng/ml.
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| Control Group | Placebo Comparator | Patients with baseline 25OH vitamin D level of 10-19 ng/ml.
Patients with baseline 25OH vitamin D level of 20-29 ng/ml.
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| Observational Group | Other | Patients with a baseline Vitamin D level below 10 ng/ml.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement |
| ||
| Calcium carbonate |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml). | 6 months for randomized phase, 12 months for open-label phase |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic. | 6 months for randomized phase, 12 months for open-label phase | |
| To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Antonella Rastelli, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Dietary Supplement |
|
| Vitamin D | Drug |
|
| Placebo | Other |
|
| 6 months |
| To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms. | 6 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
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