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 Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Breast Cancer; Osteoporosis

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Estimated Enrollment :	560 participants
Observational Model:	Case Control
Time Perspective:	Cross-Sectional
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
Study Start Date :	August 2008
Actual Study Completion Date :	June 2009

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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. [ Time Frame: once ]

Secondary Outcome Measures :

1. 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. [ Time Frame: once ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	55 Years to 65 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Institute of Oncology

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Slovenia
Research Site
Ljubljana, Slovenia

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Simona Borstnar, MD, PhD	Institute of Oncology Ljubljana

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Meta Jeras, Mr Ph, Regulatory and Medical Affairs Manager, AstraZeneca UK Limited, Branch Office in Slovenia
ClinicalTrials.gov Identifier:	NCT00767585 History of Changes
Other Study ID Numbers:	NIS-OSI-DUM-2008/1
First Posted:	October 7, 2008
Last Update Posted:	July 3, 2009
Last Verified:	July 2009

Keywords provided by AstraZeneca:

breast cancer; aromatase inhibitors; bone mineral density; osteoporosis

Additional relevant MeSH terms:

Fractures, Bone; Bone Diseases, Metabolic; Bone Diseases; Breast Neoplasms; Osteoporosis; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Musculoskeletal Diseases	Metabolic Diseases; Wounds and Injuries; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs