Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qamar Khan; University of Kansas
• Collaborators: BTR Group; Novartis Pharmaceuticals
• Treatments: Aromatase Inhibitors; Cholecalciferol; Ergocalciferols; Letrozole; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor

• Serum 25OHD levels < 40 ng/ml

Exclusion Criteria:

• Severe or debilitating musculoskeletal pain

• Known metastatic disease

• History of renal stones

• History of hypercalcemia or hyperthyroidism

• Currently receiving adjuvant or neoadjuvant chemotherapy

• Currently receiving other investigational agents