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

 -  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.
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