Breast Cancer Clinical Trial
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
Verified date | July 2009 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Slovenia: Agency for Medicinal Products - Ministry of Health |
Study type | Observational |
The aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.
Status | Completed |
Enrollment | 560 |
Est. completion date | June 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 55 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Women aged 55-65 years, diagnosed with invasive early breast cancer: - Surgery, chemo- and/or radiotherapy concluded less than 6 months ago - Women with hormone-independent breast cancer: - Surgery, chemo- and/or radiotherapy concluded before 24-36 months or 54-66 months - Women with hormone-dependent breast cancer:- Adjuvant therapy with tamoxifen initiated before 24-36 and 54-66 months or - Adjuvant therapy with aromatase inhibitor initiated before 24-36 and 54-66 months or - Switch from tamoxifen to aromatase inhibitor initiated before 24-36 months Exclusion Criteria: - Women receiving active treatment for osteoporosis - Women with any evidence of breast cancer recurrence |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Slovenia | Research Site | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the effect of aromatase inhibitors therapy on bone mineral density as measured by DEXA scan and compare it to the effects of tamoxifen and no hormonal therapy. | once | Yes | |
Secondary | To determine the bone fracture rate in women on aromatase inhibitors therapy and compare it to fracture rates observed in the tamoxifen and the hormone-independent group. | once | Yes |
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