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A 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 - Article


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Vitamin C (Ascorbic Acid)

 




Clinical Trial: A 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

This study is not yet open for patient recruitment.
Verified by Washington University School of Medicine December 2005

Sponsored by: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00263185

Purpose

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.
Condition Intervention
Breast Neoplasms
 Drug: Vitamin D
 Drug: Calcium carbonate

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Factorial Assignment

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

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

• Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) •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 •Marginal 25 OH Vitamin D level (between 10 and 29 ng/ml) •24-hour urine Calcium excretion < 250 mg/g •A history of generalized musculoskeletal pain with or without localized regions of 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 •History of medical or psychiatric condition which may preclude protocol compliance •Normal 25 OH vitamin D level (>30 ng/ml)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00263185

Rizwanna Chohan      314-362-3855 

Missouri
      Washington University, St. Louis,  Missouri,  63110,  United States

Study chairs or principal investigators

Antonella Rastelli, M.D.,  Principal Investigator,  Washington University School of Medicine   

More Information

Study ID Numbers:  05-0498
Last Updated:  December 8, 2005
Record first received:  December 6, 2005
ClinicalTrials.gov Identifier:  NCT00263185
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10


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December 2, 2009



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