Breast Cancer, Osteoporosis
Conditions
Keywords
breast cancer, aromatase inhibitors, bone mineral density, osteoporosis
Brief summary
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Slovenia
Outcome results
None listed