High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a pilot, double-blind, randomized, placebo-controlled study with the following aims: 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). 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. To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms. 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.

Official Title
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A Double-Blind, Randomized, Placebo Controlled Trial of High Dose Vitamin D Therapy On Musculoskeletal Symptoms and Bone Mineral Density in Anastrozole-Treated Early Stage Breast Cancer Patients With Marginal Vitamin D Status

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Calcium carbonate
* Drug: Vitamin D
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) or ductal carcinoma in situ (DCIS) Postmenopausal status Completed at least 8 weeks of anastrozole as adjuvant therapy prior to study entry Completed systemic chemotherapy and radiation treatments when indicated Serum Calcium ≤ 10.3 mg/dL Patients with marginal 25 OH Vitamin D level (between 10 and 29 ng/ml) will be in the Randomized Group or Low 25 OH Vitamin D level (less than 10 ng/ml) will be in Observational Group 24-hour urine Calcium excretion ≤ 250 mg/g (calculated by dividing 24 hour calcium by 24 hour creatinine) A history of generalized musculoskeletal pain with or without localized regions or discomfort that has developed or worsened since starting adjuvant aromatase inhibitor therapy Exclusion Criteria Known metastatic disease History of kidney stones History of active primary hyperparathyroidism History of Paget's disease of the bone History of severe arthritis, rheumatoid arthritis, or severe neuropathy Normal 25 OH Vitamin D level (≥ 30 ng/ml) Medical or psychiatric condition which may preclude protocol compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment Group<br>Patients with baseline 25OH vitamin D level of 10-19 ng/ml. Calcium carbonate 1000 mg/day Vitamin D 400 units daily. Vitamin 50,000 IU/wk x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. Calcium carbonate 1000 mg/day Vitamin D 400 units daily. Vitamin 50,000 IU/wk x 8 weeks and then once a month for a total of 6 months. | Dietary Supplement: Vitamin D<br> <br> Dietary Supplement: Calcium carbonate<br> <br> Drug: Vitamin D<br> <br> |
| Placebo Comparator: Control Group<br>Patients with baseline 25OH vitamin D level of 10-19 ng/ml. Calcium carbonate 1000 mg/day Vitamin D 400 units daily. Placebo once per week x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. Calcium carbonate 1000 mg/day Vitamin D 400 units daily. Placebo once per week x 8 weeks and then once a month for a total of 6 months. | Dietary Supplement: Vitamin D<br> <br> Dietary Supplement: Calcium carbonate<br> <br> Other: Placebo<br> <br> |
| Other: Observational Group<br>Patients with a baseline Vitamin D level below 10 ng/ml. Calcium carbonate 1000 mg/day Vitamin D 400 units daily. | Dietary Supplement: Vitamin D<br> <br> Dietary Supplement: Calcium carbonate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |