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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00767585
First received: October 6, 2008
Last updated: July 2, 2009
Last verified: July 2009
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 560
Study Start Date: August 2008
Study Completion Date: June 2009
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
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, see Learn About Clinical Studies.

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

Locations
Slovenia
Research Site
Ljubljana, Slovenia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Simona Borstnar, MD, PhD Institute of Oncology Ljubljana
  More Information

No publications provided

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
Study First Received: October 6, 2008
Last Updated: July 2, 2009
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

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
Wounds and Injuries
Musculoskeletal Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014