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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00767585

Recruitment Status : Completed

First Posted : October 7, 2008

Last Update Posted : July 3, 2009

Sponsor:

Information provided by:

AstraZeneca

Study Description

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


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Bone Density Breast Cancer Fractures Minerals

U.S. FDA Resources

Groups and Cohorts

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

Primary Outcome Measures :

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 :

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	55 Years to 65 Years (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767585

Locations


Slovenia
Research Site
Ljubljana, Slovenia

Sponsors and Collaborators

AstraZeneca

Investigators


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

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 Key Record Dates
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

To Top