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

Early Phase 1CompletedNCT00263185

Washington University School of Medicine63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Breast Neoplasms

Interventions

Vitamin DDIETARY_SUPPLEMENT

Calcium carbonateDIETARY_SUPPLEMENT

Vitamin DDRUG

PlaceboOTHER

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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).

Time frame: 6 months for randomized phase, 12 months for open-label phase

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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