Status:
TERMINATED
Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Breast Cancer
Musculoskeletal Disease
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The third generation oral aromatase inhibitors (AIs) are increasingly being used in the management of estrogen receptor positive breast cancer. One of the issues related with administration of oral AI...
Eligibility Criteria
Inclusion
- Postmenopausal status
- Currently being treated with an AI in the adjuvant setting (minimum for 8 weeks)
- AIMSS as determined by new or worsened musculoskeletal complaints following AI therapy
- Vitamin D deficiency (\<30ng/ml)
- Caucasian
Exclusion
- Hormone replacement therapy last 6 months
- Current use or in the last 12 months of bisphosphonates
- Tamoxifen use in last 6 months
- History of kidney stones
- History of hypercalcemia/hypercalciuria or hyperthyroidism
- Paget's disease of the bone
- Current use of Digitalis/digoxin or thiazide diuretics
- Current use of vitamin D (or multivitamin) supplementation should be stopped
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01809171
Start Date
October 1 2013
End Date
August 1 2015
Last Update
October 21 2015
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Belgium