Status:
COMPLETED
Vitamin D3 for Aromatase Inhibitor Induced Arthralgias
Lead Sponsor:
Qamar Khan
Collaborating Sponsors:
Novartis Pharmaceuticals
BTR Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protoco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00867217
Start Date
March 1 2009
End Date
January 1 2011
Last Update
February 9 2018
Active Locations (2)
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1
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
2
Cancer Centers of Kansas, P.A.
Wichita, Kansas, United States, 67214