Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer in Real World Clinical Settings in Greece
Subjects with ER-positive early breast cancer will be treated with AIs either as first line
therapy or as maintenance therapy after initial treatment with chemotherapy. The total study
duration will be 24 months comprising of a recruitment period of 12 months and a follow-up
period of 12 months for each participating subject. The primary outcome variable is the mean
percentage variation in lumbar spine bone mineral density during the 12 month follow - up
period. Measurements will be taken before and after chemotherapy and at the end of the 12
month follow - up period.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Mean percentage change in lumbar spine bone mineral density from baseline (before chemotherapy commencement) to month 12 of AI therapy
13-18 months months
Yes
Christos J Markopoulos, MD, MPhil
Principal Investigator
Associate Professor of Surgery-Athens University Medical School, Director of the Breast Unit-Athens Medical Centre Private Hospital
Greece: National Organization of Medicines
POCHARBI - 2010/02
NCT01298362
March 2011
March 2014
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