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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT00263185

Run by

Washington University School of Medicine

People needed

63

Starts

2005-11-01

Expected to finish

2009-11-01

Last updated by the study team

2014-09-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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