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OpenTrials
Completed

NCT Number: NCT00767585

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 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.

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Key information

Conditions

Breast Cancer Bone Diseases Bone Diseases, Metabolic Breast Diseases Breast Neoplasms Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Osteoporosis Skin Diseases Skin and Connective Tissue Diseases

Age range

55 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Research Site

Ljubljana, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2008
Study completion
2009
First posted
Oct 7, 2008
Registry last updated
Jul 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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