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:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00767585
First received: October 6, 2008
Last updated: July 2, 2009
Last verified: July 2009
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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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
| 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)
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B
70 women with hormone-independent early breast cancer, 24-36 months after completion of chemo- and/or radiotherapy
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|
C
70 women with hormone-independent early breast cancer, 54-66 months after completion of chemo- and/or radiotherapy
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|
D
70 women with hormone-dependent early breast cancer, 24-36 months after initiation of tamoxifen therapy
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|
E
70 women with hormone-dependent early breast cancer, 24-36 months after initiation of aromatase inhibitors therapy
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F
70 women with hormone-dependent early breast cancer, 54-66 months after initiation of tamoxifen therapy
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|
G
70 women with hormone-dependent early breast cancer, 54-66 months after initiation of aromatase inhibitors therapy
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|
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| Ages Eligible for Study: | 55 Years to 65 Years (Adult) |
| Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767585
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | October 6, 2008 |
| Last Updated: | July 2, 2009 |
| Health Authority: | Slovenia: Agency for Medicinal Products - Ministry of Health |
Keywords provided by AstraZeneca:
|
breast cancer aromatase inhibitors bone mineral density osteoporosis |
Additional relevant MeSH terms:
|
Fractures, Bone Bone Diseases, Metabolic Bone Diseases Breast Neoplasms Osteoporosis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Musculoskeletal 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 |
ClinicalTrials.gov processed this record on September 28, 2016