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CompletedNCT00767585Updated Jul 3, 2009

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

An observational study in Breast Cancer and Osteoporosis, sponsored by AstraZeneca. Completed at 1 site in Slovenia. Open to female participants aged 55 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-07-03.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
560
Ages
55 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Osteoporosis

Keywords

  • breast cancer
  • aromatase inhibitors
  • bone mineral density
  • osteoporosis
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 560 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Institute of Oncology

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Women receiving active treatment for osteoporosis
  • Women with any evidence of breast cancer recurrence
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
560 participants (estimated)

Groups and 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

06

What researchers measure

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

07

Study locations

1 site
  • Research Site
    Ljubljana, Slovenia
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2008 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2008
First posted
Oct 7, 2008
Start
Aug 2008
CompletionActual
Jun 2009
Last update
Jul 3, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00767585
Lead sponsor
AstraZeneca
First posted
Oct 7, 2008
Start date
Aug 2008
Completion
Jun 2009
Last update
Jul 3, 2009

Study contacts

Simona Borstnar, MD, PhD
principal investigator · Institute of Oncology Ljubljana

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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