An open label non-interventional evaluation of the effect of adjuvant hormonal treatment of postmenopausal women wih early breast cancer with aromatase inhibitors on bone mineral density and bone fracture rate in daily practice
Study identifier:NIS-OSI-DUM-2008/1
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An open label non-interventional evaluation of the effect of adjuvant hormonal treatment of postmenopausal women wih early breast cancer with aromatase inhibitors on bone mineral density and bone fracture rate in daily practice
Medical condition
Breast Cancer
Phase
-
Healthy volunteers
No
Study drug
-
Sex
Female
Actual Enrollment
560
Study type
Observational
Age
55 Years - 65 Years
Date
Study Start Date: 01 Aug 2008
Primary Completion Date: -
Study Completion Date: 01 Jun 2009
Study design
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| A: 70 women with hormone-dependent or hormone-independent early breast cancer that have completed their chemo- and/or radiotherapy just recently (up to 6 months after completion of therapy) | - |
| B 70 women with hormone-independent early breast cancer, 24-36 months after completion of chemo- and/or radiotherapy | - |
| C 70 women with hormone-independent early breast cancer, 54-66 months after completion of chemo- and/or radiotherapy | - |
| D 70 women with hormone-dependent early breast cancer, 24-36 months after initiation of tamoxifen therapy | - |
| E 70 women with hormone-dependent early breast cancer, 24-36 months after initiation of aromatase inhibitors therapy | - |
| F 70 women with hormone-dependent early breast cancer, 54-66 months after initiation of tamoxifen therapy | - |
| G 70 women with hormone-dependent early breast cancer, 54-66 months after initiation of aromatase inhibitors therapy | - |
| H 70 women with hormone-dependent early breast cancer, 24-36 months after initiation of aromatase inhibitors therapy following 24-36 months of initial tamoxifen therapy | - |
Contacts
Investigators
Principal Investigator
Simona Borstnar
Institute of Oncology Ljubljana
