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
|
Purpose
| 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
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
Missouri
Washington University, St. Louis, Missouri, 63110, United States
Antonella Rastelli, M.D., Principal Investigator, Washington University School of Medicine
More Information
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

Not Signed In -

