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Spots Global Cancer Trial Database for High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status

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Trial Identification

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

Official Title: 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

Study ID: NCT00263185

Study Description

Brief Summary: 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: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Washington University, St. Louis, Missouri, United States

Contact Details

Name: Antonella Rastelli, M.D.

Affiliation: Washington University School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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