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 - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00767585

Purpose

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
Breast Cancer Osteoporosis

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Fractures Minerals Osteoporosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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

Further study details as provided by AstraZeneca:

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	560
Study Start Date:	August 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Eligibility

Ages Eligible for Study:	55 Years to 65 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767585

Contacts

Contact: AstraZeneca Slovenia Clinical Study, Information

+386 1 5135 602

alesa.rakar@astrazeneca.com

Locations

Slovenia
Research Site	Recruiting
Ljubljana, Slovenia

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Simona Borstnar, MD, PhD

Institute of Oncology Ljubljana

More Information

Responsible Party:	AstraZeneca UK Limited, Branch Office in Slovenia ( Meta Jeras, Mr Ph, Regulatory and Medical Affairs Manager )
Study ID Numbers:	NIS-OSI-DUM-2008/1
Study First Received:	October 6, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767585
Health Authority:	Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by AstraZeneca:

breast cancer
aromatase inhibitors
bone mineral density
osteoporosis

Study placed in the following topic categories:

Musculoskeletal Diseases
Skin Diseases
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

Osteoporosis
Breast Neoplasms
Bone Diseases, Metabolic
Bone Diseases
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009