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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:
ClinicalTrials.gov Identifier:
NCT00767585
First Posted: October 7, 2008
Last Update Posted: July 3, 2009
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.
Information provided by:
AstraZeneca
  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 ]

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 ]

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

Information from the National Library of Medicine

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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
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 Submitted: October 6, 2008
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:
Breast Neoplasms
Osteoporosis
Fractures, Bone
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone 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