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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767585
• Other study ID #: NIS-OSI-DUM-2008/1
• Status: Completed
• Phase: N/A
• First received: October 6, 2008
• Last updated: July 2, 2009
• Start date: August 2008
• Est. completion date: June 2009

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: June 2009
• 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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fractures, Bone
• Osteoporosis

Locations

Country	Name	City	State
Slovenia	Research Site	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Slovenia, 

Outcome

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