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

NCT00767585 | Completed

• 1 other identifier: NIS-OSI-DUM-2008/1
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Osteoporosis

Keywords

breast cancer; aromatase inhibitors; bone mineral density; osteoporosis

Outcome Measures

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.

  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.

  once

Study Arms (8)

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 Criteria

• Age: 55 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Institute of Oncology

You may qualify if:

• 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

You may not qualify if:

• Women receiving active treatment for osteoporosis
• Women with any evidence of breast cancer recurrence

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Simona Borstnar, MD, PhD

  Institute of Oncology Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Study Start: August 1, 2008
• Study Completion: June 1, 2009
• Last Updated: July 3, 2009

Record last verified: 2009-07

Locations

SL (1)