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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


N/A
55 Years
65 Years
Not Enrolling
Female
Breast Cancer, Osteoporosis

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

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.

Outcome Time Frame:

once

Safety Issue:

Yes

Principal Investigator

Simona Borstnar, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Oncology Ljubljana

Authority:

Slovenia: Agency for Medicinal Products - Ministry of Health

Study ID:

NIS-OSI-DUM-2008/1

NCT ID:

NCT00767585

Start Date:

August 2008

Completion Date:

June 2009

Related Keywords:

  • Breast Cancer
  • Osteoporosis
  • breast cancer
  • aromatase inhibitors
  • bone mineral density
  • osteoporosis
  • Breast Neoplasms
  • Fractures, Bone
  • Osteoporosis

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