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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: AstraZeneca
• Treatments: Anastrozole; Calcium; Calcium Carbonate; Calcium, Dietary; Ergocalciferols; Vitamin D; Vitamins

Criteria

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